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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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04.08.2026 02:01

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BGI

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAI2022010HK
Basic UDI-DI: B-SAI2022010HK
Reference: SAI2022002
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:36

Manufacturer products View details

BGI

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAI2022009J2
Basic UDI-DI: B-SAI2022009J2
Reference: SAI2022009
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:36

Manufacturer products View details

BGI

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAI2022003HN
Basic UDI-DI: B-SAI2022003HN
Reference: SAI2022003
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:36

Manufacturer products View details

BGI

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAI2022002HL
Basic UDI-DI: B-SAI2022002HL
Reference: SAI2022002
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:36

Manufacturer products View details

RadioProfile

IVD generalIVDDOn the marketProfessional testing

Manufacturer: NEOLYS Diagnostics
Manufacturer SRN: FR-MF-000036165
UDI-DI: D-RadioProfile9Z
Basic UDI-DI: B-RadioProfile9Z
Reference: RadioProfile
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 05:33

Manufacturer products View details

RadioDtect

IVD generalIVDDOn the marketProfessional testing

Manufacturer: NEOLYS Diagnostics
Manufacturer SRN: FR-MF-000036165
UDI-DI: D-RadioDtect4Z
Basic UDI-DI: B-RadioDtect4Z
Reference: RadioDtect
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: France
Authorised representative: -
Last updated: 15.07.2026 05:33

Manufacturer products View details

D-K90411-042PD

Central Nervous specific protein (S100-β) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-042PD
Basic UDI-DI: B-K90411-042PD
Reference: /
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-028PK

Cystatin C (CysC) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-028PK
Basic UDI-DI: B-K90411-028PK
Reference: /
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-022P7

Heparin Binding protein (HBP) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-022P7
Basic UDI-DI: B-K90411-022P7
Reference: /
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4494074MC

S100 Protein Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4494074MC
Basic UDI-DI: B-IM4494074MC
Reference: IM4494074
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4493074M5

S100 Protein Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4493074M5
Basic UDI-DI: B-IM4493074M5
Reference: S100 Protein Chemiluminescent Immunoassay Kit
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4407074JW

S100 Protein Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407074JW
Basic UDI-DI: B-IM4407074JW
Reference: IM4407074
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4406074JP

S100 Protein Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4406074JP
Basic UDI-DI: B-IM4406074JP
Reference: IM4406074
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403074J2

S100 Protein Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403074J2
Basic UDI-DI: B-IM4403074J2
Reference: IM4403074
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402074HT

S100 Protein Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402074HT
Basic UDI-DI: B-IM4402074HT
Reference: IM4402074
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

α‐1 Antitrypsin

I0213

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-I0213N9
Basic UDI-DI: B-I0213N9
Reference: I0213
EMDN: W0102019002
EMDN description: A1-ANTITRYPSIN (PROTEASE INHIBITOR)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:02

Manufacturer products View details

α‐1 Microglobulin

I0212

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-I0212N7
Basic UDI-DI: B-I0212N7
Reference: I0212
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:02

Manufacturer products View details

α‐1 Acid Glycoprotein

I0211

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-I0211N5
Basic UDI-DI: B-I0211N5
Reference: I0211
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:02

Manufacturer products View details

Cystatin C

I0201

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-I0201N2
Basic UDI-DI: B-I0201N2
Reference: I0201
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:02

Manufacturer products View details

Human β - amyloid protein (Aβ1-42) Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD198Y9
Basic UDI-DI: B-GKPD198Y9
Reference: GKPD198
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details