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105 device results listed.

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D-CNMF000014455-GCA-S21WD

GLU-A1C S03

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: D-CNMF000014455-GCA-S21WD
Basic UDI-DI: B-CNMF000014455-GCA-S21WD
Reference: GCA-S21
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

HUBI A1c

CFU-D1

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: CareforU.Co.Ltd
Manufacturer SRN: KR-MF-000031539
UDI-DI: D-8800210900068V9
Basic UDI-DI: B-8800210900068V9
Reference: AHA1C-8010
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Iceland
Authorised representative: Meridius Medical Europe Limited
Last updated: 12.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

CareBuddy HbA1c

CFU-D1

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: CareforU.Co.Ltd
Manufacturer SRN: KR-MF-000031539
UDI-DI: D-8800210900037UW
Basic UDI-DI: B-8800210900037UW
Reference: CDC1B02
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Iceland
Authorised representative: Meridius Medical Europe Limited
Last updated: 12.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-4-66T

H12,PH 01

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-4-66T
Basic UDI-DI: B-4-66T
Reference: /
EMDN: W0101060107
EMDN description: HBA1C 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

26935784411170

A1C-EXP S01

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 26935784411170
Basic UDI-DI: B-26935784411170
Reference: A1C-S42
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:44

Manufacturer products Authorised representative products Authorised representative actors View details

26935784400075

GLU-A1C S05

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: 26935784400075
Basic UDI-DI: B-26935784400075
Reference: GCA-S32
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:44

Manufacturer products Authorised representative products Authorised representative actors View details

26935784400068

A1C-PRO S01

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 26935784400068
Basic UDI-DI: B-26935784400068
Reference: A1C-S32
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:44

Manufacturer products Authorised representative products Authorised representative actors View details

26935784400044

GLU-A1C S03

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: 26935784400044
Basic UDI-DI: B-26935784400044
Reference: GCA-S22
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:44

Manufacturer products Authorised representative products Authorised representative actors View details

26935784400037

A1C EZ 2.0

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: 26935784400037
Basic UDI-DI: B-26935784400037
Reference: A1C-S22
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:44

Manufacturer products Authorised representative products Authorised representative actors View details

16935784411173

A1C-EXP S01

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784411173
Basic UDI-DI: B-16935784411173
Reference: A1C-S42
EMDN: W0101060107
EMDN description: HBA1C 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

16935784400078

GLU-A1C S05

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: 16935784400078
Basic UDI-DI: B-16935784400078
Reference: GCA-S32
EMDN: W0101060107
EMDN description: HBA1C 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

16935784400061

A1C-PRO S01

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784400061
Basic UDI-DI: B-16935784400061
Reference: A1C-S32
EMDN: W0101060107
EMDN description: HBA1C 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

16935784400030

A1C EZ 2.0

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: 16935784400030
Basic UDI-DI: B-16935784400030
Reference: A1C-S22
EMDN: W0101060107
EMDN description: HBA1C 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

16935784400047

GLU-A1C S03

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: 16935784400047
Basic UDI-DI: B-16935784400047
Reference: GCA-S22
EMDN: W0101060107
EMDN description: HBA1C 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

Hemoglobin Test Strips

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245011
Basic UDI-DI: B-15065026245011
Reference: TR10006
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Finland
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

TruGlyc

HbA1c Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763792
Basic UDI-DI: B-15065023763792
Reference: TG10002
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

HbA1c Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763525
Basic UDI-DI: B-15065023763525
Reference: TV20014
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

respons®A1c Hemoglobin A1c Test Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660750
Basic UDI-DI: B-08806134660750
Reference: 963207
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem A1c Advanced Hemoglobin A1c Test Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660743
Basic UDI-DI: B-08806134660743
Reference: 107033
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

QDx A1c Advance Test kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660729
Basic UDI-DI: B-08806134660729
Reference: RT100S10
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details