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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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78 device results listed.

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CERA-STAT™ 4000 Analyzer

CERA-STAT™ 4000 Analyzer

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

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065166008
Basic UDI-DI: 88000651HAAHM000C8
Reference: CS400M10
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 14:00

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE A1c Analyzer

RT-100

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

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660613
Basic UDI-DI: 88061346A1CAKV
Reference: RT100M10
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Türkiye
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

G20, G21, G60, G80

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 06972337851591
Basic UDI-DI: 697233785GHgbA010ME
Reference: G20
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:31

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Glycohemoglobin Analyzer

H50、H50P

IVD Class CIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904052137
Basic UDI-DI: 69449040AB3000012ZG
Reference: H50
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

H102 Air ，H101

IVD Class BIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010684
Basic UDI-DI: 6934175001A0620P3
Reference: 7C001
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class BIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010691
Basic UDI-DI: 6934175001A0620P3
Reference: 7C002
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class BIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010707
Basic UDI-DI: 6934175001A0620P3
Reference: 7C003
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class BIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010714
Basic UDI-DI: 6934175001A0620P3
Reference: 7C004
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class BIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175026067
Basic UDI-DI: 6934175001A0620P3
Reference: 7D001
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

TG100

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763785
Basic UDI-DI: 5065023763TG100S4
Reference: TG10001
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse PLUS Multi-Purpose Analyzer

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

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: 04713648762198
Basic UDI-DI: 47136487606B00MCSa73
Reference: M034
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

QDx A1c Advance

-

IVD Class ANot specifiedOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660620
Basic UDI-DI: 88061346A1CAKV
Reference: RT100M10
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem A1c Advanced

-

IVD Class ANot specifiedNot intended for EU marketInstrumentNear-patient testingProfessional testing

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660644
Basic UDI-DI: 88061346A1CAKV
Reference: 107032
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

respons®A1c Analyzer

-

IVD Class ANot specifiedOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660651
Basic UDI-DI: 88061346A1CAKV
Reference: 963100
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 06972337852369
Basic UDI-DI: 697233785GHgbA010ME
Reference: G21
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 27.07.2026 01:48

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin Analyzer(HPLC)

H6, H8, H9, H100, H100Plus, 96TH, A10TH, A10,

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062822
Basic UDI-DI: 6970341680120203GU
Reference: NA
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 17.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin Analyzer(HPLC)

H6, H8, H9, H100, H100Plus, 96TH, A10TH, A10,

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062815
Basic UDI-DI: 6970341680120203GU
Reference: NA
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 17.07.2026 05:29

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin Analyzer(HPLC)

H6, H8, H9, H100, H100Plus, 96TH, A10TH, A10,

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062808
Basic UDI-DI: 6970341680120203GU
Reference: NA
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

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