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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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02.08.2026 18:51

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353 device results listed.

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen BioRay Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045502
UDI-DI: 06977194141823
Basic UDI-DI: B-06977194141823
Reference: HR0203201
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-human thyroid Peroxidase antibody（TPOAb）TestKit（Fluorescence immunochromatography method）

25 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374752811
Basic UDI-DI: B-06976374752811
Reference: 25 tests / kit（DR104-3）
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroglobulin antibody（TGAb）TestKit（Fluorescence immunochromatography method）

25 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374752804
Basic UDI-DI: B-06976374752804
Reference: 25 tests / kit（DR082-3）
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

FOLATE（FA）TestKit（Fluorescence immunochromatography method）

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374752217
Basic UDI-DI: B-06976374752217
Reference: 20 tests / kit（DR103-2）
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Homocysteine(HCY)TestKit（Fluorescence immunochromatography method）

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374752194
Basic UDI-DI: B-06976374752194
Reference: 20 tests / kit（DR074-2）
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

IgE antibody Test Kit（Fluorescence immunochromatography method）

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374752187
Basic UDI-DI: B-06976374752187
Reference: 20 tests / kit（DR083-2）
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Anti streptolysin O (ASO) Test Kit（Fluorescence immunochromatography method）

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374752156
Basic UDI-DI: B-06976374752156
Reference: 20 tests / kit（DR077-2）
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12（VB12）Test Kit（Fluorescence immunochromatography method）

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374752088
Basic UDI-DI: B-06976374752088
Reference: 20 tests / kit（DR075-2）
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Gastrin 17(G-17)TestKit（Fluorescence immunochromatography method）

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374752026
Basic UDI-DI: B-06976374752026
Reference: 20 tests / kit（DR073-2）
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen I and Pepsinogen II (PGI/PGII)Test Kit（Fluorescence immunochromatography method）

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374751968
Basic UDI-DI: B-06976374751968
Reference: 20 tests / kit（DR072-2）
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

C-Peptide (C-P) Test Kit（Fluorescence immunochromatography method）

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374751364
Basic UDI-DI: B-06976374751364
Reference: 20 tests / kit（DR060-2）
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Test Kit (Fluorescence immunochromatography method)

50 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374750411
Basic UDI-DI: B-06976374750411
Reference: 50 tests / kit（DR015-2）
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Test Kit (Fluorescence immunochromatography method)

25 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374750404
Basic UDI-DI: B-06976374750404
Reference: 25 tests / kit（DR015-4）
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Test Kit (Fluorescence immunochromatography method)

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374750398
Basic UDI-DI: B-06976374750398
Reference: 20 tests / kit（DR015-1）
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

PROM Amniotic fluid Test

GHPROM

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762678
Basic UDI-DI: B-06976202762678
Reference: GHPROM-702
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

PROM Amniotic fluid Rapid Test

GHPROM

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762326
Basic UDI-DI: B-06976202762326
Reference: GHPROM-702
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

PCT/CRP Test Kit (Dry Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06975260987337
Basic UDI-DI: B-06975260987337
Reference: 0117-03
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

SAA/CRP Test Kit (Dry Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06975260980451
Basic UDI-DI: B-06975260980451
Reference: 0118-03
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

20 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Avioq Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000048146
UDI-DI: 06975166204460
Basic UDI-DI: B-06975166204460
Reference: 20 Tests/Kit
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

40 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Avioq Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000048146
UDI-DI: 06975166204477
Basic UDI-DI: B-06975166204477
Reference: 40 Tests/Kit
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details