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513 device results listed.

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Wellion AMADEUS

Wellion AMADEUS Blood Glucose Test Strips

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603C3TY5
Basic UDI-DI: B-47136487603C3TY5
Reference: S5641137, S5641138
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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

GlucoSure Advance II

GlucoSure Advance II Blood Glucose Test Strips

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603C1TXX
Basic UDI-DI: B-47136487603C1TXX
Reference: S5640626 S5640680 S5640679 S5641126
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure POC Compact

GlucoSure POC Compact Blood Glucose Test strips

IVD generalIVDDNo longer on the marketMicrobial substancesNear-patient testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603B1TXS
Basic UDI-DI: B-47136487603B1TXS
Reference: S5641004 S5641005 S5641006 S5641007
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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

GlucoSure HT

GlucoSure HT blood glucose test strips

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487602AT7U
Basic UDI-DI: B-47136487602AT7U
Reference: S5640693, S5640758, S5640657, S5640895, S5640918, S5640659
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

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GlucoSure Autocode

GlucoSure AutoCode blood glucose test strips

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487601AT7P
Basic UDI-DI: B-47136487601AT7P
Reference: S5636096, S5640087, S5640249, S5640809, S5640259, S5636097, S5640088, S5640808, S5640751, S5640887, S5641016, S5641017
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure Link

GlucoSure Link Blood Glucose test strips

IVD Annex II List BIVDDNo longer on the marketMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487601A1TX7
Basic UDI-DI: B-47136487601A1TX7
Reference: S70453 S70454 S70455
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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

D-4-16H

URIT G25,URIT G26,URIT G28,URIT G28 No coding,URIT G80 No coding

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testingSingle use

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-4-16H
Basic UDI-DI: B-4-16H
Reference: /
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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

GLUCOCARD G sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-38995JR
Basic UDI-DI: B-38995JR
Reference: 38995
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 18:58

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GLUCOCARD G sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-34847HD
Basic UDI-DI: B-34847HD
Reference: 34847
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD G sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-33699HF
Basic UDI-DI: B-33699HF
Reference: 33699
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

16935784450073

GM S01

IVD self-testing devicesIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784450073
Basic UDI-DI: B-16935784450073
Reference: GLU-S42
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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

16935784420052

GLU-A1C S06

IVD self-testing devicesIVDDOn the marketKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784420052
Basic UDI-DI: B-16935784420052
Reference: GLU-S32
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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

16935784400054

GLU-A1C S04

IVD self-testing devicesIVDDOn the marketKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784400054
Basic UDI-DI: B-16935784400054
Reference: GLU-S22
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:57

Manufacturer products Authorised representative products Authorised representative actors View details

TruReno

Blood Glucose Test Strips

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763983
Basic UDI-DI: B-15065023763983
Reference: TR10002
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Cyprus
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109574NR
Basic UDI-DI: B-109574NR
Reference: 109574
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:46

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S (GT-7110)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109523N8
Basic UDI-DI: B-109523N8
Reference: 109523
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:46

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W Test Strips

IVD Annex II List BIVDDNo longer on the marketMicrobial substancesReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109516NB
Basic UDI-DI: B-109516NB
Reference: 109516
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:46

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W Test Strips

IVD Annex II List BIVDDNo longer on the marketMicrobial substancesReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109514N7
Basic UDI-DI: B-109514N7
Reference: 109514
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:46

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S Test Strips

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109333MZ
Basic UDI-DI: B-109333MZ
Reference: 109333
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:46

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S Test Strips

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109332MX
Basic UDI-DI: B-109332MX
Reference: 109332
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:46

Manufacturer products Authorised representative products Authorised representative actors View details