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558 device results listed.

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GLUCOCARD SM (GT-7120)

IVD Annex II List BIVDDNo longer on the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47396HZ
Basic UDI-DI: B-47396HZ
Reference: 47396
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

AP-10

IVD self-testing devicesIVDDOn the marketInstrumentSelf testing

Manufacturer: Leison Biotech Co., Ltd.
Manufacturer SRN: TW-MF-000026417
UDI-DI: D-471987421AP-10METER8SJN
Basic UDI-DI: B-471987421AP-10METER8SJN
Reference: N/A
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

Wellion AMADEUS

Wellion AMADEUS Set

IVD Annex II List BIVDDOn the marketInstrumentKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603C367
Basic UDI-DI: B-47136487603C367
Reference: S70522, S70523
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse A1C

Eclipse A1C Hemoglobin A1c POC analyzer

IVD generalIVDDNo longer on the marketAnimal tissuesInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487600B05F
Basic UDI-DI: B-47136487600B05F
Reference: S54133, S54144, S54145, S54119
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD Vital (GT-1050)

IVD Annex II List BIVDDNo longer on the marketInstrumentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46907HX
Basic UDI-DI: B-46907HX
Reference: 46907
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46748J3
Basic UDI-DI: B-46748J3
Reference: 46748
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Croatia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46746HX
Basic UDI-DI: B-46746HX
Reference: 46746
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46744HT
Basic UDI-DI: B-46744HT
Reference: 46744
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46708HP
Basic UDI-DI: B-46708HP
Reference: 46708
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46745HV
Basic UDI-DI: B-46745HV
Reference: 46745
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46707HM
Basic UDI-DI: B-46707HM
Reference: 46707
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46706HK
Basic UDI-DI: B-46706HK
Reference: 46706
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-4-76V

URIT-12,PH-01,PH-01A

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-4-76V
Basic UDI-DI: B-4-76V
Reference: /
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-4-26K

URIT-25,URIT-26,URIT-28,URIT-82,URIT-86

IVD Annex II List BIVDDOn the marketInstrumentProfessional testingSelf testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-4-26K
Basic UDI-DI: B-4-26K
Reference: /
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

Contour®

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: Ascensia Diabetes Care Holdings AG
Manufacturer SRN: CH-MF-000034124
UDI-DI: D-3412481721220SN
Basic UDI-DI: B-3412481721220SN
Reference: 81721220
EMDN: W020106019085
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - CONSUMABLES
First on market country: Spain
Authorised representative: Ascensia Diabetes Care Italy Srl
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Contour®

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: Ascensia Diabetes Care Holdings AG
Manufacturer SRN: CH-MF-000034124
UDI-DI: D-3412467075397L
Basic UDI-DI: B-3412467075397L
Reference: 6707539
EMDN: W020106019085
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: Ascensia Diabetes Care Italy Srl
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Contour®

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: Ascensia Diabetes Care Holdings AG
Manufacturer SRN: CH-MF-000034124
UDI-DI: D-3412467075046Z
Basic UDI-DI: B-3412467075046Z
Reference: 6707504
EMDN: W020106019085
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - CONSUMABLES
First on market country: Finland
Authorised representative: Ascensia Diabetes Care Italy Srl
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

206 Rapid Test

260

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-2606Y
Basic UDI-DI: B-2606Y
Reference: 206-01
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:48

Manufacturer products Authorised representative products Authorised representative actors View details

16935784450004

GM 1.0

IVD self-testing devicesIVDDOn the marketInstrumentProfessional testingSelf testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784450004
Basic UDI-DI: B-16935784450004
Reference: GLU-M11
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

16935784420267

GLU-A1C M24

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingSelf testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784420267
Basic UDI-DI: B-16935784420267
Reference: GCA-M42
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details