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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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HbA1c Rapid Quantitative Test

HbA1c Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: D-300015BUV
Basic UDI-DI: B-300015BUV
Reference: HU-RE-F07F032001
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

CRP (C-reactive protein) Rapid Quantitative Test

CRP (C-reactive protein) Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490527
Basic UDI-DI: B-06975679490527
Reference: HU-RE-F07F035002
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Quantitative Test

CK-MB Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490428
Basic UDI-DI: B-06975679490428
Reference: HU-RE-F07F044002
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Rapid Quantitative Test

HbA1c Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490503
Basic UDI-DI: B-06975679490503
Reference: HU-RE-F07F032002
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Rapid Test Kit

cTnI Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490510
Basic UDI-DI: B-06975679490510
Reference: HU-RE-F07F034002
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

PCT (Procalcitonin) Rapid Quantitative Test

PCT (Procalcitonin) Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490466
Basic UDI-DI: B-06975679490466
Reference: HU-RE-F07F046002
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

IL-6 Rapid Quantitative Test

IL-6 Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490459
Basic UDI-DI: B-06975679490459
Reference: HU-RE-F07F047002
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Rapid Test Kit

D-Dimer Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490435
Basic UDI-DI: B-06975679490435
Reference: HU-RE-F07F045002
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Rapid Test Kit

NT-proBNP Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490411
Basic UDI-DI: B-06975679490411
Reference: HU-RE-F07F061002
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH-VD Rapid Quantitative Test

25-OH-VD Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490404
Basic UDI-DI: B-06975679490404
Reference: HU-RE-F08F027002
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin Rapid Quantitative Test

Ferritin Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490398
Basic UDI-DI: B-06975679490398
Reference: HU-RE-F07F036002
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Dry immunoassay analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576207665
Basic UDI-DI: 697457620SSDiaXY
Reference: 1FF00003
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 11.08.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

PLGF Rapid Quantitative Test (Chemiluminescence Immunoassay)

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IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205998
Basic UDI-DI: B-06933260205998
Reference: BT0503901
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

INS Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260206049
Basic UDI-DI: B-06933260206049
Reference: BT0504001
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay)

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IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207329
Basic UDI-DI: B-06933260207329
Reference: BT0506001
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

SCC Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207466
Basic UDI-DI: B-06933260207466
Reference: BT0506405
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Rapid Quantitative Test

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208470
Basic UDI-DI: B-06933260208470
Reference: BT2301
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Amphetamine (AMP) Saliva Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140747
Basic UDI-DI: B-06958982140747
Reference: AD07-S20
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 07.08.2026 15:29

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Marijuana (THC) Saliva Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140730
Basic UDI-DI: B-06958982140730
Reference: AD06-S20
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 07.08.2026 15:29

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Cocaine (COC) Saliva Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140723
Basic UDI-DI: B-06958982140723
Reference: AD05-S20
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 07.08.2026 15:29

Manufacturer products Authorised representative products Authorised representative actors View details