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275 device results listed.

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BM Test HbA1c Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: JEOL Ltd. MF
Manufacturer SRN: JP-MF-000026608
UDI-DI: D-780609981T6
Basic UDI-DI: B-780609981T6
Reference: 780609981
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Netherlands
Authorised representative: JEOL(Europe)BV AR
Last updated: 12.07.2026 09:25

Manufacturer products Authorised representative products Authorised representative actors View details

BM Test HbA1c Reagent 2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: JEOL Ltd. MF
Manufacturer SRN: JP-MF-000026608
UDI-DI: D-780609972T5
Basic UDI-DI: B-780609972T5
Reference: 780609972
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Netherlands
Authorised representative: JEOL(Europe)BV AR
Last updated: 12.07.2026 09:25

Manufacturer products Authorised representative products Authorised representative actors View details

BM Test HbA1c Reagent 1

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: JEOL Ltd. MF
Manufacturer SRN: JP-MF-000026608
UDI-DI: D-780609956T7
Basic UDI-DI: B-780609956T7
Reference: 780609956
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Netherlands
Authorised representative: JEOL(Europe)BV AR
Last updated: 12.07.2026 09:25

Manufacturer products Authorised representative products Authorised representative actors View details

Chromatographic Column (HPLC) Z-Hb Confirm

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ZOVEC diagnostics GmbH
Manufacturer SRN: DE-MF-000035393
UDI-DI: 42625753901532
Basic UDI-DI: B-42625753901532
Reference: Z-RHBCC
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:42

Manufacturer products View details

D-1606T

Hemoglobin A1c Kit (Enzymatic Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-1606T
Basic UDI-DI: B-1606T
Reference: /
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 08:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-11R8E

Hemoglobin A1c Assay Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-11R8E
Basic UDI-DI: B-11R8E
Reference: /
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

ASUREQUAN HbA1c

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: EMPECS Medical Device Co., Ltd.
Manufacturer SRN: KR-MF-000029619
UDI-DI: 08809328960865
Basic UDI-DI: B-08809328960865
Reference: CP501001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Belgium
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

CLOVER A1c Plus Test Cartridge

IHM-0003

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagent

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115907134
Basic UDI-DI: B-08809115907134
Reference: OHHS03A
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Sweden
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

CLOVER A1c Plus Test Cartridge

IHM-0003

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115906236
Basic UDI-DI: B-08809115906236
Reference: OHHS03ASP
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

CLOVER A1c Plus Test Cartridge

IHM-0003

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904911
Basic UDI-DI: B-08809115904911
Reference: OHHS03ACZ
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

CLOVER A1c Self Test Cartridge

IGM-0023

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904881
Basic UDI-DI: B-08809115904881
Reference: INFHS02ASCZ
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

HemoCue HbA1c 501 Test Cartridge

IGM-0026B

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagent

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115902559
Basic UDI-DI: B-08809115902559
Reference: 405110
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Sweden
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

CLOVER A1c Self Test Cartridge

IGM-0023

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115902092
Basic UDI-DI: B-08809115902092
Reference: 920404
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

CLOVER A1c Self Test Cartridge

INFHS01AS2

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115901767
Basic UDI-DI: B-08809115901767
Reference: INFHS01AS2
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

CLOVER A1c Self Test Cartridge

IGM-0023

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115902054
Basic UDI-DI: B-08809115902054
Reference: 920404
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

CLOVER A1c Test Cartridge

IGM-0023

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagent

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115901019
Basic UDI-DI: B-08809115901019
Reference: INFHS02B
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Sweden
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

CLOVER A1c Plus Test Cartridge

IHM-0003

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08800323056133
Basic UDI-DI: B-08800323056133
Reference: OHHS03A
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Sweden
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900944

SimplexTAS 101 HbA1c Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900944
Basic UDI-DI: B-08800037900944
Reference: T0101002
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

HBA1C II DİREKT KİTİ

HBA1C II DIRECT REAGENT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08699015289535
Basic UDI-DI: B-08699015289535
Reference: 06R72-30
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 16:13

Manufacturer products View details

HBA1C II DİREKT KİTİ

HBA1C II DIRECT REAGENT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08699015289528
Basic UDI-DI: B-08699015289528
Reference: 06R72-20
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 16:13

Manufacturer products View details