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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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817 device results listed.

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Total-P1NP CLIA

IVD generalNot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06942609216328
Basic UDI-DI: B-06942609216328
Reference: GPP88K2
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Total-P1NP CLIA

IVD generalNot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06942609216250
Basic UDI-DI: B-06942609216250
Reference: GPP88K0N
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Total-P1NP CLIA

IVD generalNot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06942609216267
Basic UDI-DI: B-06942609216267
Reference: GPP88K5N
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Total-P1NP CLIA

IVD generalNot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06942609216274
Basic UDI-DI: B-06942609216274
Reference: GPP88K3N
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Total-P1NP CLIA

IVD generalNot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06942609216281
Basic UDI-DI: B-06942609216281
Reference: GPP88K2N
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Dry immunoassay analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576209522
Basic UDI-DI: 697457620SSDiaXY
Reference: 1FF00019
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:56

Manufacturer products Authorised representative products Authorised representative actors View details

Washing Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576209836
Basic UDI-DI: 697457620FGWS01QT
Reference: GFQXY30Q
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:56

Manufacturer products Authorised representative products Authorised representative actors View details

Substrate Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576205876
Basic UDI-DI: 697457620FGSS01PX
Reference: GFQXY04B
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:55

Manufacturer products Authorised representative products Authorised representative actors View details

Substrate Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576205883
Basic UDI-DI: 697457620FGSS01PX
Reference: GFQXY00B
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:55

Manufacturer products Authorised representative products Authorised representative actors View details

Fully automatic chemiluminescence immunoassay analyzer

IVD Class ANot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576209874
Basic UDI-DI: 697457620SSFaciaMP
Reference: 2FF00005
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

Fully automatic chemiluminescence immunoassay analyzer

AI-120

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576208587
Basic UDI-DI: 697457620SSFaciaMP
Reference: 2FF00001
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE CLIA

IVD generalNot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06942609218025
Basic UDI-DI: B-06942609218025
Reference: GGE03K0N
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE CLIA

IVD generalNot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06942609218032
Basic UDI-DI: B-06942609218032
Reference: GGE03K5N
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE CLIA

IVD generalNot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06942609218049
Basic UDI-DI: B-06942609218049
Reference: GGE03K3N
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE CLIA

IVD generalNot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06942609218056
Basic UDI-DI: B-06942609218056
Reference: GGE03K2N
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE CLIA

IVD generalNot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06942609218063
Basic UDI-DI: B-06942609218063
Reference: GGE03K0
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE CLIA

IVD generalNot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06942609218070
Basic UDI-DI: B-06942609218070
Reference: GGE03K5
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE CLIA

IVD generalNot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06942609218087
Basic UDI-DI: B-06942609218087
Reference: GGE03K3
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE CLIA

IVD generalNot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06942609218094
Basic UDI-DI: B-06942609218094
Reference: GGE03K2
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Immunofluorescence Assay

IVD generalNot specifiedOn the market

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06975599464981
Basic UDI-DI: B-06975599464981
Reference: GP-DD09-D
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details