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80 device results listed.

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D-EC9404001B9

Glycated Hemoglobin Analyzer Column S

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EC9404001B9
Basic UDI-DI: B-EC9404001B9
Reference: EC9404001
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 13.07.2026 18:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-EC9403001B2

Glycated Hemoglobin Analyzer Column S

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EC9403001B2
Basic UDI-DI: B-EC9403001B2
Reference: EC9403001
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 13.07.2026 18:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455HP-M51-GBQ

BH60G

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455HP-M51-GBQ
Basic UDI-DI: B-CNMF000014455HP-M51-GBQ
Reference: HP-M51-G
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 05:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-A1C-M41L8

A1C-EXP M11

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-A1C-M41L8
Basic UDI-DI: B-CNMF000014455-A1C-M41L8
Reference: A1C-M41
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
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

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

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

16935784411074

A1C-EXP M12

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784411074
Basic UDI-DI: B-16935784411074
Reference: A1C-M42
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
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

16935784410015

A1C EZ 2.0 BT

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784410015
Basic UDI-DI: B-16935784410015
Reference: A1C-M22
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
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

16935784410008

A1C EZ 2.0

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784410008
Basic UDI-DI: B-16935784410008
Reference: A1C-M21
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
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

14560189283432

G7 HSi Elution Buffer No.3 (S)

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189283432
Basic UDI-DI: B-14560189283432
Reference: 0019546
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

14560189283425

G7 HSi Elution Buffer No.2 (S)

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189283425
Basic UDI-DI: B-14560189283425
Reference: 0019545
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

14560189283418

G7 HSi Elution Buffer No.1 (S)

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189283418
Basic UDI-DI: B-14560189283418
Reference: 0019544
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

CLOVER A1c Self Analyzer

IGM-0023

IVD self-testing devicesIVDDOn the marketInstrumentReagentSelf testing

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900760
Basic UDI-DI: B-08809115900760
Reference: INFH01AS2
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
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

CERA-STAT™ 2000 Analyzer

CS 2000

IVD generalIVDDNo longer on the marketInstrumentNear-patient testingProfessional testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065164004
Basic UDI-DI: B-08800065164004
Reference: CS200M10
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

LabonaCheck™ A1c HbA1c Analyzer

MH 200

IVD generalIVDDNo longer on the marketInstrumentNear-patient testingProfessional testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065162406
Basic UDI-DI: B-08800065162406
Reference: MH200M10
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

06978189071019

10 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Yantai JIEZI Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000044146
UDI-DI: 06978189071019
Basic UDI-DI: B-06978189071019
Reference: 10 tests/kit
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

06973861683955

HbA1c Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861683955
Basic UDI-DI: B-06973861683955
Reference: A02017002
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:42

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Glycohemoglobin Analyzer

IVD Class CNot specifiedOn the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904052144
Basic UDI-DI: 69449040AB3000012ZG
Reference: H50P
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

ASUREQUAN Analyzer

EMBC-MT01

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: EMPECS Medical Device Co., Ltd.
Manufacturer SRN: KR-MF-000029619
UDI-DI: 08809328960872
Basic UDI-DI: 880932896EMBCMT01BL
Reference: EMBCMT01-EN01
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.07.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

HemoCue HbA1c 501 Analyzer

IGM-0026BM

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115902542
Basic UDI-DI: 880911590IGM0026BMUN
Reference: 405210
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Sweden
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:45

Manufacturer products Authorised representative products Authorised representative actors View details