№ з/п

№ сертифікату

Термін дії від

Термін дії до

Заявник

Виробник

Production

1.

PR.005-17

22.02.2017

21.02.2022

Evolutis S.A.S., France

Evolutis S.A.S., France

Articular and osteosynthesis prostheses and associated ancillaries

2.

PR.006-17

22.02.2017

21.02.2022

Evolutis S.A.S.,

France

Evolutis S.A.S.,

France

Articular and osteosynthesis prostheses and associated ancillaries

3.

PR.007-17

23.02.2017

22.02.2022

Іnfopia Co., Ltd., Republic of Korea

Іnfopia Co., Ltd., Republic of Korea

Products for determination of tumor markers (PSA)

Blood glucose measuring systems for self-testing

Self-test for Lipid Profile and Glucose

4.

PR.009-17

23.02.2017

22.02.2022

Osstem Implant Co., Ltd., Korea

Osstem Implant Co., Ltd., Korea

Dental Implants and Surgical Kits

5.

PR.010-17

24.02.2017

23.02.2022

U&I Corporation, Korea

U&I Corporation, Korea

Spinal Intervertebral body fixation orthosis devices

6.

PR.011-17

29.03.2017

28.03.2022

Arthrex Inc.,

USA

Arthrex Inc., USA

Implantable Plates, Posts, Screws, Staples and Washers for arthroscopic surgery

Implantable Anchors for arthroscopic surgery

Buttons and sutures

Instrumentation and devices for arthroscopic and orthopedic surgery

Equipment, devices and instruments for arthroscopy

Implants for anatomical resurfacing

Bioabsorbable Fixation Implants

Prosthesis Systems

7.

PR.012-17

29.03.2017

28.03.2022

Arthrex Inc., Inc., USA

Arthrex Inc., USA

Bioabsorbable Fixation Implants

Prosthesis Systems

8.

PR.013-17

13.04.2017

12.04.2022

LABORATORIES URGO, France

LABORATORIES URGO, France

URGO CORICIDE, medical plaster

Sterile lipido-colloid plaster URGO Burns

URGO Antiseptic, medical plasters

Products for the hygiene of the nasal cavity

9.

PR.014-17

13.04.2017

12.04.2022

LABORATORUIES URGO, France

LABORATORIES ERGO, France

URGO CORICIDE, medical plaster

10.

PR.015-17

13.04.2017

12.04.2022

LABORATORIES URGO, France

LABORATORIES URGO, France

Sterile lipido-colloid plaster URGO Burns

11.

PR.016-17

28.04.2017

27.04.2022

Bermedi Medical Solutions GmbH

Bermedi Medical Solutions GmbH, Germany

Medical X-Ray films

12.

PR.017-17

28.04.2017

27.04.2022

UAB “Medicinos linija”, Lithuania

UAB “Medicinos linija”, Lithuania

Dental materials i-dental

13.

№ PR.019-17

09.06.2017

08.06.2022

ЗАТ «Медицинское предприятие Симург», Республіка Білорусь

ЗАТ «Медицинское предприятие Симург», Республіка Білорусь

Instruments gynecological

Speculums gynecological (Kusco)

Probes “Yunona”

Aspiration probes “Yunona”

Gynecological sets “Yunona”

Disposable obstetrical pessaries

Sets of laminaria sticks “Yunona”

Uterine pessaries “Yunona”

Silicone pessaries

Intrauterine contraceptive devices “Yunona Bio-T”

14.

№ PR.020-17

09.06.2017

08.06.2022

ЗАТ «Медицинское предприятие Симург», Республіка Білорусь

ЗАТ «Медицинское предприятие Симург», Республіка Білорусь

Intrauterine contraceptive devices “Yunona Bio-T”

15.

№ PR.022-17

22.06.2017

21.06.2022

Admedus Regen Pty Ltd, Australia

Admedus Regen Pty Ltd, Australia

Cardiovascular patches CardioCel

16.

№ PR.024-17

27.06.2017

26.06.2022

Coltène /Whaledent AG, Switzerland

Coltène /Whaledent AG, Switzerland

Materials for Restorative Dentistry, Attachments Used in Dentistry, Burs/Polishers Used in Dentistry Burs/Polires

17.

№ PR.025-17

27.06.2017

26.06.2022

EURONDA SPA, Italy

EURONDA SPA, Italy

Autoclaves

Suction accessories

Single use instant ice

18.

№ PR.026-17

29.06.2017

28.06.2022

Coltène /Whaledent GmbH + Co. KG, Germany

Coltène /Whaledent GmbH + Co. KG, Germany

Root canal filling materials

Paper points

Aspirator tips

Root canal files

Medicated gelatin sponges

19.

№ PR.027-17

29.06.2017

28.06.2022

Coltène /Whaledent GmbH + Co. KG, Germany

Coltène /Whaledent GmbH + Co. KG, Germany

Medicated gelatin sponges

20.

№ PR.028-17

30.06.2017

29.06.2022

Tecnofar s. p. a.,

Italy

Tecnofar s. p. a.,

Italy

MASTER dental needles

21.

№ PR.029-17

07.07.2017

06.07.2022

ТОВ «Львівський завод РЕМА», Україна

ТОВ «Львівський завод РЕМА», Україна

Electrocardiographs

Defibrillators

Pulse Oximeters

Patient monitoring systems

Physiotherapy equipment

22.

№ PR.030-17

19.07.2017

18.07.2022

W&H Dentalwerk Bürmoos GmbH, Austria

W&H Dentalwerk Bürmoos GmbH, Austria

Active dental equipment and accessories, active surgical equipment

23.

№ PR.031-17

19.07.2017

18.07.2022

W&H Sterilization Srl, Italy

W&H Sterilization Srl, Italy

Small Steam Sterilizer Lisa VA131-17

Small Steam Sterilizer Lisa VA131-22

Small Steam Sterilizer Lina РRO13-003-17

Small Steam Sterilizer Lina РRO13-003-22

24.

№ PR.032-17

21.07.2017

20.07.2022

TAU STERIL DI BIANCHI G.E.C. SNC, Italy

TAU STERIL DI BIANCHI G.E.C. SNC, Italy

Tau Clave 3000

Tau Clave 3000 Vacuum

Tau Clave 3000 Fractinated Vacuum

Tau Clave Fast  B

25.

№ PR.033-17

21.07.2017

20.07.2022

Guna S. p. a., Italy

Guna S. p. a., Italy

Collagen medical devices:

– MD-HIP

– MD-KNEE

– MD-LUMBAR

– MD-NECK

– MD-SHOULDER

– MD-SMALL JOINTS

– MD-ISCHIAL

– MD-MUSCLE

– MD-NEURAL

– MD-POLY

– MD-THORACIC

– MD-MATRIX

– MD-TISSUE

26.

№ PR.034-17

21.07.2017

20.07.2022

Guna S. p. a., Italy

Guna S. p. a., Italy

Collagen medical devices:

– MD-HIP

– MD-KNEE

– MD-LUMBAR

– MD-NECK

– MD-SHOULDER

– MD-SMALL JOINTS

– MD-ISCHIAL

– MD-MUSCLE

– MD-NEURAL

– MD-POLY

– MD-THORACIC

– MD-MATRIX

– MD-TISSUE

28.

№ PR.039-17

21.07.2017

20.07.2022

ТОВ «ЛІЗОФОРМ МЕДІКАЛ», Україна

ТОВ «ЛІЗОФОРМ МЕДІКАЛ», Україна

Плівки радіографічні і

флюорографічні медичні

29.

№ PR.040-17

04.08.2017

03.08.2022

Tuttnauer Ltd., Israel

Tuttnauer Ltd., Israel

Autoclaves

30.

№ PR.041-17

04.08.2017

03.08.2022

Forum Engineering Technologies (96) Ltd., Israel

Forum Engineering Technologies (96) Ltd., Israel

NovАрех арех locator N-21

NovАрех арех locator N-31

BINGO PRO арех locator В-31

Bingo-1020 арех locator

31.

№ PR.042-17

07.08.2017

06.08.2022

i.com medical GmbH, Germany

i.com medical GmbH, Germany

Ocutears® Eye Drops

32.

№ PR.043-17

07.08.2017

06.08.2022

Santen, France

Santen, France

Cationorm® Protective Eye Drops, emulsion

33.

№ PR.044-17

07.08.2017

06.08.2022

Kuraray Noritake Dental Inc., Japan

Kuraray Noritake Dental Inc., Japan

Dental Porcelain Noritake Super Porcelain EX-3

Dental Porcelain CERAВIEN ZR

Dental Porcelain ЕХ-3 PRESS

Dental Porcelain ЕХ-3 PRESS LF

Dental Porcelain CZR PRESS

Dental Porcelain CZR PRESS LF

Dental Porcelain SCREENING PORCELAIN

Dental Ceramic Block KATANA Zirconia

34.

№ PR.045-17

31.08.2017

30.08.2022

Zhuhai SIGER Medical Equipment Co., Ltd., P.R. China

Zhuhai SIGER Medical Equipment Co., Ltd., P.R. China

Dental Units U500, U200, U100, S30, S60, S90, V6000, V5000, V2000, V1000; Ultrasonic scalers and Ultrasonic scaler tips, Ultrasonic periodontal treatment devices and Ultrasonic scaler tips; High frequency DC X ray units SIRAY, SIRAY PLUS; steam sterilizers EGO-17B, EGO-17B+, EGO-23B, EGO-23B+

35.

№ PR.046-17

01.09.2017

31.08.2017

BМТ Medical Technology s.r.o., Czech Republic

BМТ Medical Technology s.r.o., Czech Republic

Steam sterilizers Sterident, Sterimat, Sterimat plus, Sterilab,

Unisteri HP, Unisteri HP IL,

Unisteri SL, Sterivap, Sterivap SL, Sterivap HP, Sterivap HP IL,

Selectomat SL

Washer desinfectors Uniclean SL M, Uniclean SL MS,

Uniclean SL L, Uniclean SL LS,

Uniclean SL TS

Hot air sterilizers  Stericell

36.

№ PR.047-17

08.09.2017

07.09.2022

MEDGAL Sp. z o. o., Poland

MEDGAL Sp. z o. o., Poland

Intramedullary locking nail, bone nails, bone pins, bone staples, bone wires

Bone screws

Bone plates

Implants for maxillofasial surgery

Modular hemi hip joint prosthesis “FENIX”

Orthopaedic surgical instruments for implants insertion and implants removal

Implants for osteosynthesis

Implants for osteosynthesis DLC or SI-DLC coated

37.

№ PR.048-17

08.09.2017

07.09.2022

Yuhuan County Shengbo Mould Manufacturing Co., Ltd., China

Yuhuan County Shengbo Mould Manufacturing Co., Ltd., China

Disposable gynecological sets

Disposable gynecological instruments

38.

№ PR.049-17

08.09.2017

07.09.2022

MMM Münchener Medizin Mechanik GmbH, Germany

MMM Münchener Medizin Mechanik GmbH, Germany

Steam sterilizers Selectomat PL

Formaldehyde sterilizers Formomat PL

Washer disinfectors Uniclean ML, Uniclean PL II

Disinfection chambers Vacudes PL

39.

№ PR.051-17

20.09.2017

19.09.2022

Nakanishi Inc., Japan

Nakanishi Inc., Japan

Insruments and equipment in Dental and Surgical Fields

40.

№ PR.052-17

26.09.2017

25.09.2022

F. M. S.p.A., Italy

F. M. S.p.A., Italy

Bloodlines and accessories for hemodialysis

41.

№ PR.053-17

29.09.2017

28.09.2022

Novo Nordisk A/S, Denmark

Novo Nordisk A/S, Denmark

NovoPen® 4

NovoPen Echo®

NovoFine®

42

№ PR.055-17

06.10.2017

05.10.2022

SKB-MET LLC, Ukraine

SKB-MET LLC, Ukraine

Electrode for stimulation of cardiac activity through the esophageal PEDSP-2

Electrode endocardial monopole for temporal stimulation of cardiac activity of EPVP

Electrode conductors, diagnostic multiconducting PEDM

Provided electrodes temporary indifferent PEVs

43

№ PR.056-17

06.10.2017

05.10.2022

SKB-MET LLC, Ukraine

SKB-MET LLC, Ukraine

Electrode endocardial monopole for temporal stimulation of cardiac activity of EPVP

Electrode conductors, diagnostic multiconducting PEDM

Electrode conductors, temporary indifferent PEVs

44

№ PR.057-17

09.10.2017

08.10.2022

Hologic Inc., USA

Hologic Inc., USA

QDR SERIES X-RAY BONE DENSITOMETERS:

DISCOVERY Ci

DISCOVERY Wi

HORIZON A

HORIZON C

HORIZON Ci

HORIZON W

HORIZON Wi

FLUOROSCAN C-ARM IMAGING SYSTEMS:

InSight 2

InSight FD

MAMMOGRAPHY SYSTEMS:

SDA-SYS-3000-2D Selenia Dimensions

SDA-SYS-3000-3D Selenia Dimensions

SDM-SYS-6000-2D Selenia Dimensions

SDM-SYS-6000-3D Selenia Dimensions

SDM-SYS-9000-2D Selenia Dimensions

SDM-SYS-9000-3D Selenia Dimensions

3DM-SYS-INTL2D 3Dimensions

3DM-SYS-INTL3D 3Dimensions

BREAST BIOPSY GUIDANCE SYSTEMS:

STLC-00004 AFFIRM

PRONE BIOPSY SYSTEMS:

PBX-SYS-AFFIRM-2D AFFIRM

PBX-SYS-AFFIRM-3D AFFIRM

45

№ PR.058-17

10.10.2017

09.10.2022

Accuray Incorporated, USA

Accuray Incorporated, USA

CyberKnife® Treatment Delivery System (CyberKnife® M6, CyberKnife® M6FI, CyberKnife® M6FI+, CyberKnife® M6FIM, CyberKnife® M6FM, CyberKnife® M6FI with Neuro Package)

TomoTherapy® Treatment Delivery System (TomoTherapy® TomoH, TomoTherapy® TomoHD, TomoTherapy® TomoHDA)

Radixact® Treatment Delivery System (Radixact® X5, Radixact® X7, Radixact® X9)

Planning System Accuray Precision

Data Management System iDMS

46

№ PR.059-17

18.10.2017

17.10.2022

Aero Medikal Saglik Turizmi Tibbi Ürünler ve lth. Ihr. San.Tic. Ltd. Sti, Turkey

Aero Medikal Saglik Turizmi Tibbi Ürünler ve lth. Ihr. San.Tic. Ltd. Sti, Turkey

Spinal Implant Systems:

Screws

Rods

Connectors

Cages

Corpectomy Cages

Disc Prosthesises

Hooks

Cervical Plates

47

№ PR.060-17

18.10.2017

17.10.2022

VEDA.LAB, France

VEDA.LAB, France

hCG pregnency test for self-testing BABYCHECK-1

hCG pregnency test for self-testing BABYCHECK-1+

hCG pregnency test for self-testing BABYCHECK-1 №2

49

№ PR.062-17

26.10.2017

25.10.2022

Colenta Labortechnik Ges. m.b.h. & CO KG, Austria

Colenta Labortechnik Ges. m.b.h. & CO KG, Austria

Medical X-Ray films:

MEDIPHOT X-90/RP

MEDIPHOT X-90N/RP

MEDIPHOT X-O/RP

MEDIPHOT X-MA/RP

50

№ PR.063-17

27.10.2017

26.10.2022

Krka, d.d., Novo mesto, Slovenia

Krka, d.d., Novo mesto, Slovenia

SeptoAqua®, for children

nasal spray, solution

SeptoAqua®, for adults

nasal spray, solution

51

№ PR.064-17

23.11.2017

22.11.2022

Likon LLC, Ukraine

Likon LLC, Ukraine

Contact lenses:

Lileya 40

Olimpia UV

Olimpia-h

Lileya-color

RGP

52

№ PR.065-17

01.12.2017

30.11.2022

MedBioAlyans LLC, Ukraine

MedBioAlyans LLC, Ukraine

Immuno-enzyme reagents for in vitro diagnostic markers of infectious diseases

Sets of immunoassay test systems for diagnosing markers of infectious diseases

Standard and control panels of human serum for monitoring the quality of immunoassay studies of markers of infectious diseases

Sets of tests for conducting research by immunochromatographic analysis

53

№ PR.066-17

01.12.2017

30.11.2022

MedBioAlyans LLC, Ukraine

MedBioAlyans LLC, Ukraine

Immuno-enzyme reagents for in vitro diagnostic markers of infectious diseases

Sets of immunoassay test systems for diagnosing markers of infectious diseases

Standard and control panels of human serum for monitoring the quality of immunoassay studies of markers of infectious diseases

Sets of tests for conducting research by immunochromatographic analysis

54

№ PR.067-17

01.12.2017

30.11.2022

MedBioAlyans LLC, Ukraine

MedBioAlyans LLC, Ukraine

Sets of tests for conducting research by immunochromatographic analysis

Quick tests for determining biochemical parameters in urine

55

№ PR.068-17

06.12.2017

05.12.2022

Ortho-Space Ltd, Israel

Ortho-Space Ltd, Israel

Biodegradable implantable balloon for rotator cuff syndrome InSpace system

56

№ PR.069-17

06.12.2017

05.12.2022

Ortho-Space Ltd, Israel

Ortho-Space Ltd, Israel

Biodegradable implantable balloon for rotator cuff syndrome InSpace system

57

№ PR.071-17

20.12.2017

31.07.2022

Pharmacosmetic-Diafarm G.Soultogiannis & Co E.E., Greece

Pharmacosmetic-Diafarm G.Soultogiannis & Co E.E., Greece

Nasal sterile seawater spray ATHOMER

58

№ PR.072-17

27.12.2017

23.01.2022

Greiner Bio-One GmbH, Austria

Greiner Bio-One GmbH, Austria

HOLDEX® Single Use Holder

59

№ PR.073-17

27.12.2017

31.07.2019

Greiner Bio-One GmbH, Austria

Greiner Bio-One GmbH, Austria

VACUETTE® Multiple Use Drawing Needles

VACUETTE® VISIO PLUS Needles

60

№ PR.074-17

27.12.2017

31.07.2019

Greiner Bio-One GmbH, Austria

Greiner Bio-One GmbH, Austria

VACUETTE® QUICKSHIELD Complete

VACUETTE® QUICKSHIELD Plus Complete

61

№ PR.075-17

27.12.2017

22.01.2022

Greiner Bio-One GmbH, Austria

Greiner Bio-One GmbH, Austria

VACUETTE® Luer Adapter

62

№ PR.076-17

27.12.2017

13.10.2022

Greiner Bio-One GmbH, Austria

Greiner Bio-One GmbH, Austria

SAFETY Blood Collection/Infusion Set

SAFETY Blood Collection Set + Holder

SAFETY Blood Collection Set + Luer Adapter

SAFETY Blood Collection Set + HOLDEX®

SAFETY Blood Collection Set + Blood Culture Holder

Blood Collection/Infusion Set

Blood Collection Set + Holder

Blood Collection Set +

Blood Collection Set + Blood Culture Holder

63

№ PR.077-17

27.12.2017

23.10.2018

Greiner Bio-One GmbH, Austria

Greiner Bio-One GmbH, Austria

MiniCollect® Sfety Lancets

64

№ PR.079-18

11.01.2018

10.01.2023

Diagnostic Systems Ukraine LLC, Ukraine

Diagnostic Systems UkraineLLC, Ukraine

Medical device for in vitro diagnostics (according to Annex to Certificate)

65

№ PR.080-18

11.01.2018

10.01.2023

Diagnostic Systems Ukraine LLC, Ukraine

Diagnostic Systems Ukraine LLC, Ukraine

Medical device for in vitro diagnostics (according to Annex to Certificate)

66

№ PR.081-18

24.01.2018

03.09.2020

OPTOTEK d.o.o., Slovenia

OPTOTEK d.o.o., Slovenia

Medical therapeutic laser system OptoYag M

Medical therapeutic laser system OptoSLT M

Medical therapeutic laser system OptoYag&SLT M

Medical therapeutic laser system OptoSLT nano

67

№ PR.082-18

31.01.2018

30.01.2023

EKOBYNT Ltd, Ukraine

EKOBYNT Ltd, Ukraine

Medical instruments for ophthalmic and laryngoscopes, disposable medical sterile

Sets and tools for medical examinations of single use sterile

Clothing, accessories and medical supplies and kits based on them are sterile

Wool medical hygroscopic eye sterile

Wool medical hygroscopic surgical sterile

Wool medical hygroscopic hygienic sterile

Bandages gauze medical sterile

68

№ PR.083-18

06.02.2018

05.02.2023

Soleko S. p. A., ITALY

Soleko S. p. A., ITALY

Contact lenses and contact lens care products

69

№ PR.084-18

12.02.2018

11.02.2023

Amann Girrbach AG, Austria

Amann Girrbach AG, Amann Girrbach AG, Austria

Ceramill Liquid fx

Ceramill Liquid

Ceramill SINTRON ZZ

Ceramill SINTRON

Ceramill ZI

Ceramill ZOLID fx Multilayer

Ceramill ZOLID fx preshade

Ceramill ZOLID fx

Ceramill ZOLID HT+ white

Ceramill Zolid HT+ preshade

Ceramill ZOLID preshade

Ceramill ZOLID (according to Annexes to certificate)

70

№ PR.085-18

01.03.2018

28.02.2023

INTEROJO INC., Korea

INTEROJO INC., Korea

Contact lenses:

Morning Q 55UV, Morning Q BIO, Morning Q 38,

PolyVue HD, Morning Q 1-DAY, Bandage, Adria 2 Tone,

Adria 3 Tone, Adria Festival 2 Tone, Adria Festival 1 Tone,

Adria Festival 3 Tone, Festival II, 0202, 0202 Toric, 0202

Multifocal,  0202 1-Day, Adria Impression, Adria Classic,

Adria Premium, Adria Fusion, Adria Natural, Adria Frutti,

Adria Suave, Adria Diamond, Adria Glamorous,

Adria Elegance, AdriaPastel, Adria Top Model, Adria Neon,

Adria New Look, Adria Charming, Adria Rainbow,

Adria FreshVue

71

№ PR.086-18

05.03.2018

04.03.2023

Yuhuan City Shengbo Mould Manufacturing Co., Ltd., China

Yuhuan City Shengbo Mould Manufacturing Co., Ltd., China

Disposable gynecological sets Disposble gynecological tools

72

№ PR.087-18

21.03.2018

10.08.2021

Suzhou Victor Medical Equipment Co., Ltd, P.R. China

Suzhou Victor Medical Equipment Co., Ltd, P.R. China

Dental units V100, V286, V586, AM6015

73

№ PR.088-18

21.03.2018

09.08.2021

Shenzhen Browiner Tech. Co., Ltd, P.R. China

Shenzhen Browiner Tech. Co., Ltd, P.R. China

Digital Radiography Systems:

MobileSparkler 300A

MobileSparkler 300B

MobileSparkler 300C

MobileGenius A

MobileGenius B

74

№ PR.089-18

23.05.2018

22.05.2023

Orich Medical Equipment (Tianjin) Co., Ltd, China

Orich Medical Equipment (Tianjin) Co., Ltd, China

Medical x-ray systems (according to Annex 1 to certificate)

75

№ PR.090-18

23.05.2018

22.05.2023

Shanghai Shiyin Photoelectric Instruments Co., Ltd., China

Shanghai Shiyin Photoelectric Instruments Co., Ltd., China

Medical endoscope cameras, medical endoscope cold light sources, medical endoscopic electrosurgical units, medical endoscope gas insufflators, medical endoscope irrigation pumps, medical endoscopic pumps, medical endoscopic shavers, medical endoscopic morcellators, medical endoscopic lithotriptors, medical flexible endoscopes, medical rigid endoscopes, medical endoscopic equipment (forceps; scissors; electrodes; instrument sets)

76

№ PR.091-18

25.05.2018

06.10.2021

NUEVA FEDESA, S. A., Spain

NUEVA FEDESA, S. A., Spain

Dental Equipment, Podological Equipment

78

№ PR.092-18

31.05.2018

30.05.2023

TEKNOMEK MEDIKAL MALZEMELERI SANAYI

ve TICARET LTD. STI., TURKEY

TEKNOMEK MEDIKAL MALZEMELERI SANAYI

ve TICARET LTD. STI., TURKEY

Silicone oil

Ophthalmic Gases

Viscoelastik solution, Sodium hyaluronate

Ophthalmic Cannulas, Needles, Backflush

DCR and Lacrimal Intubation set

Microsurgical Instruments

High flow filter and Syringe

Tubing systems – Injection and Extraction System

Intravitreal and Phaco kit

Perfluorodecaline

Ophthalmic dyes (Tekno Epi Blue and Tekno Capsule Blue)

77

№ PR.093-18

01.06.2018

15.10.2022

Sirtex Medical Limited, Australia

Sirtex Medical Limited, Australia

Sir-Spheres Y-90 resin microspheres SIR-Y001 (and associated devices: Delivery Set, V-Vial)

79

№ PR.094-18

01.06.2018

15.10.2022

Sirtex Medical Limited, Australia

Sirtex Medical Limited, Australia

Sir-Spheres Y-90 resin microspheres SIR-Y001 (and associated devices: Delivery Set, V-Vial)

80

№ PR.095-18

15.06.2018

14.06.2023

EUROGINE, S.L., Spain

EUROGINE, S.L., Spain

Intrauterine devices

81

№ PR.096-18

15.06.2018

14.06.2023

EUROGINE, S.L., Spain

EUROGINE, S.L., Spain

Intrauterine devices

82

№ PR.097-18

15.06.2018

14.06.2023

Research and Production Company «ELEPS» LLС, Republic of Tatarstan

Research and Production Company «ELEPS» LLС, Republic of Tatarstan

Set of Instruments  for Endoscopic Surgery IEH-” ElePS

Optical Tubes “ТО- ElePS “

Endoscopic Aspirator-irrigator AIE-15/15-“ElePS”

Electronic Endoscopic Insufflator IEE-1/30-” ElePS”

HF electrosurgical generator  EHVCH- “ElePS” in the following versions: HF electrosurgical generator  EHVCH-200 “ElePS” and HF electrosurgical generator    EHVCH-300 “ElePS”

Medical Pump for injection of solutions PM-01-“ElePS”

Rotary Shaver  SHR-01- “ElePS” in the following versions: with RU.1 Handpiece, with RO.1 Handpiece, with RO.2 Handpiece, with RO.3 Handpiece, with RO.4 Handpiece.

Endoscopic Videocamera EVK-“ElePS”

Monopolar and Bipolar Instruments, Patient Return Pads, Instruments Holders and Electrodes for HF Electrosurgical Genarators

83

№ PR.098-18

15.06.2018

14.06.2023

Lysoform Dr. Hans Rosemann GmbH, Germany

Lysoform Dr. Hans Rosemann GmbH, Germany

Disinfectants

84

№ PR.099-18

06.07.2018

05.07.2023

Geister Medizintechnik GmbH, Germany

Geister Medizintechnik GmbH, Germany

Electro Surgical Units, HF-Electrodes, HF-Instruments, Sterile Instruments, Endoscopes, Suction and Irrigation Instruments, Retractors, Bulldogs Clamp, Trocars and battery-powered Systems incl. Accessories

85

№ PR.100-18

06.07.2018

21.06.2019

TaiDoc Technology Corporation, Taiwan

TaiDoc Technology Corporation, Taiwan

Blood Glucose Monitoring System Gamma Diamond GD 50

Blood Glucose Monitoring System Gamma Diamond Prima

Blood Glucose Monitoring System Gamma Mini

Blood Glucose Monitoring System Gamma Diamond Voice

Blood Glucose Monitoring System Gamma Diamond Nano

Blood Glucose Monitoring System 2B Comfort

Blood Glucose Test Strip DM

Blood Glucose Test Strip MS

Blood Glucose Test Strip 2B Comfort

Blood Glucose Control Solution

86

№ PR.101-18

06.07.2018

21.06.2019

TaiDoc Technology Corporation, Taiwan

TaiDoc Technology Corporation, Taiwan

Sterile Blood Lancet

Lancing device

87

№ PR.102-18

13.07.2018

16.03.2021

Institut Straumann AG, Switzerland

Institut Straumann AG, Switzerland

Implants, dental materials, prosthetic components, medical Software and their systems/instruments for use in oral and extraoral implantology (maxillo-facial surgery) and dental prosthetic restoration

88

№ PR.103-18

18.07.2018

17.10.2022

Bionime Corporation, Taiwan

Bionime Corporation, Taiwan

Blood Glucose Monitoring System Rightest GM110

Blood Glucose Monitoring System Rightest GM300

Blood Glucose Monitoring System Rightest GM550

Blood Glucose Monitoring System Rightest GM700

Blood Glucose Monitoring System Rightest GM700S

Blood Glucose Monitoring System iMedico GM 700 SB

Blood Glucose Monitoring System Rightest GM720

Blood Glucose Test Strip Rightest GS 300

Blood Glucose Test Strip Rightest GS 550

Blood Glucose Test Strip Rightest GS 700

Blood Glucose Test Strip iMedico GS 700

Blood Glucose Control Solution

89

№ PR.104-18

02.08.2018

14.07.2020

Jiangsu Bonss Medical Technology Co Ltd, China

Jiangsu Bonss Medical Technology Co Ltd, China

Radio Frequency Plasma Surgical System

Radio Frequency Electrodes

90

№ PR.105-18

03.08.2018

31.03.2023

Bicon, LLC, USA

Bicon, LLC, USA

Dental implant systems and abutment

Sterile resorbable dental bone graft materials

Fibre resin material for dental prosthetics

91

№ PR.106-18

03.08.2018

19.03.2023

Bicon, LLC, USA

Bicon, LLC, USA

Uncoated sterile dental titanium implant systems

Sterile dental titanium implants systems with hydroxyapatite

92

№ PR.107-18

03.08.2018

08.03.2019

Bicon, LLC, USA

Bicon, LLC, USA

SynthoGraft resorbable dental bone graft substitute

93

№ PR.108-18

10.08.2018

09.08.2023

APHARM s.r.l., Italy

APHARM s.r.l., Italy

Vijoint – prefilled syringe with 1,6% solution of sodium hyaluronate

Vijoint One – prefilled syringe with 2% solution of sodium hyaluronate

94

№ PR.109-18

10.08.2018

09.08.2023

APHARM s.r.l., Italy

APHARM s.r.l., Italy

Vijoint – prefilled syringe with 1,6% solution of sodium hyaluronate

Vijoint One – prefilled syringe with 2% solution of sodium hyaluronate

95

№ PR.110-18

15.08.2018

14.08.2023

Fuji Systems Corporation, Japan

Fuji Systems Corporation, Japan

Intravascular Baloon Occlusion Catheters

96

№ PR.111-18

15.08.2018

14.08.2023

Fuji Systems Corporation, Japan

Fuji Systems Corporation, Japan

Intravascular Baloon Occlusion Catheters

97

№ PR.112-18

22.08.2018

19.08.2022

Anhui Hongyu Wuzhou Medical Manufacturer Со., Ltd., P.R. China

Anhui Hongyu Wuzhou Medical Manufacturer Со., Ltd., P.R. China

Sterile Hypodermic Syringes for Single Use

Sterile Hypodermic Needles for Single Use

Sterile Insulin Syringes for Single Use

Insulin Pen Needles for Single Use

Transfusion Sets for Single Use

Infusion Sets for Single Use

Intravenous Needles for Single Use

98

№ PR.113-18

03.09.2018

02.09.2023

BELLCO S.r.l., Italy

BELLCO S.r.l., Italy

Haemodialysis, apheresis and blood management equipment (including accessories for monitoring of blood pressure, oxygen saturation and heart rate); hemodialysis, apheresis and blood management disposable medical devices like filters and blood lines, plasmafilters and adsorbers, hd catheters, catridges for haemodialysis, powder concentrates for haemodialysis, liquid concentrates for haemodialysis

99

№ PR.114-18

07.09.2018

04.08.2020

Edelweiss DR AG, Switzerland

Edelweiss DR AG, Switzerland

INSPIRO direct dental nano-hybrid composite materials

(according to annex 1 to certificate)