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110 device results listed.

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HbA1c Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-OHA-R402(AT)HU
Basic UDI-DI: B-OHA-R402(AT)HU
Reference: OHA-R402
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Rapid Test Cassette

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OHA-R402(ACRO)RS
Basic UDI-DI: B-OHA-R402(ACRO)RS
Reference: OHA-R402
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for HbA1c

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315755
Basic UDI-DI: B-04260163315755
Reference: 07HBA5025
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:39

Manufacturer products View details

HbA1c Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983188708
Basic UDI-DI: B-06936983188708
Reference: OHA-402
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

PixoTest HbA1c Test Kit

IVD generalNot specifiedOn the marketSingle use

Manufacturer: iXensor Co., Ltd.
Manufacturer SRN: TW-MF-000026279
UDI-DI: 04719872951254
Basic UDI-DI: B-04719872951254
Reference: 1254
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S255S2

BF S25

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S255S2
Basic UDI-DI: B-CNMF000014455-BF-S255S2
Reference: BF-S255
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S254RY

BF S25

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S254RY
Basic UDI-DI: B-CNMF000014455-BF-S254RY
Reference: BF-S254
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S253RW

BF S25

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S253RW
Basic UDI-DI: B-CNMF000014455-BF-S253RW
Reference: BF-S253
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S252RU

BF S25

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S252RU
Basic UDI-DI: B-CNMF000014455-BF-S252RU
Reference: BF-S252
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S251RS

BF S25

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S251RS
Basic UDI-DI: B-CNMF000014455-BF-S251RS
Reference: BF-S251
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-A076DG

INDICAID® Glucose Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A076DG
Basic UDI-DI: B-A076DG
Reference: INDICAID® Glucose Rapid Test
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

G322001218BL8

HCA-TE-300

IVD Class AIVDR 2017/746Not intended for EU marketReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: G322001218BL8
Basic UDI-DI: ++G322001218BL8
Reference: NA
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

BGI

50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAI2022020HN
Basic UDI-DI: B-SAI2022020HN
Reference: SAI2022020
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:36

Manufacturer products View details

BGI

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAI2022019J5
Basic UDI-DI: B-SAI2022019J5
Reference: SAI2022019
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:36

Manufacturer products View details

BGI

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAI2022018J3
Basic UDI-DI: B-SAI2022018J3
Reference: SAI2022018
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:36

Manufacturer products View details

BGI

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAI2022005HS
Basic UDI-DI: B-SAI2022005HS
Reference: SAI2022005
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:36

Manufacturer products View details

GREENCARE A1c Hemoglobin A1c Test Kit

IVD generalIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: D-KR-MF-000015840BS
Basic UDI-DI: B-KR-MF-000015840BS
Reference: RT100S10
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Quantitative Test Kit (Time-Resolved FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIHBA-402aSW
Basic UDI-DI: B-FIHBA-402aSW
Reference: FIHBA-402a
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Quantitative Test Kit (Time-Resolved FIA)

FIHBA-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FIHBA-402aHGPC
Basic UDI-DI: B-FIHBA-402aHGPC
Reference: FIHBA-402a
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-FI-HBA-402HX

HbA1c Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-HBA-402HX
Basic UDI-DI: B-FI-HBA-402HX
Reference: FI-HBA-402
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details