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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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122 device results listed.

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Carisoprodol Rapid Test

DCAR1001 DCAR1002 DCAR1004

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DCAR100PY
Basic UDI-DI: B-DCAR100PY
Reference: DCAR1001, DCAR1002, DCAR1004
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 13.08.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Ketamine Rapid Test

DKET1001, DKET1002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DKET100V2
Basic UDI-DI: B-DKET100V2
Reference: DKET1001, DKET1002
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.08.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test Cassette (WB/S/P)

IDAB4212

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IDAB421Q9
Basic UDI-DI: B-IDAB421Q9
Reference: IDAB4212
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.08.2026 22:52

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Monkeypox Virus PCR Test Kit

IMPX00Na

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IMPX00N6W
Basic UDI-DI: B-IMPX00N6W
Reference: IMPX00Na
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.08.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

SAA/CRP FIA

YfSC4212

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-YfSC421K2
Basic UDI-DI: B-YfSC421K2
Reference: YfSC4212
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

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PCT FIA

YfPCT4002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-YfPCT400DW
Basic UDI-DI: B-YfPCT400DW
Reference: YfPCT4002
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

IL-6 FIA

YfILS4002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-YfILS400DX
Basic UDI-DI: B-YfILS400DX
Reference: YfILS4002
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

HCG Pregnancy Rapid Tests

WHCG2001, WHCG2002, WHCG2004, WHCG2003

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-WHCG2002M
Basic UDI-DI: B-WHCG2002M
Reference: WHCG2001, WHCG2002, WHCG2004,WHCG2003
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

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HCG Pregnancy Rapid Tests

WHCG1001, WHCG1002, WHCG1003

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-WHCG1002G
Basic UDI-DI: B-WHCG1002G
Reference: WHCG1001, WHCG1002, WHCG1003
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio Cholerae O1 Antigen Rapid Test

IVCA6002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IVCA600Y4
Basic UDI-DI: B-IVCA600Y4
Reference: IVCA6002
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Tuberculosis Rapid Test

ITB4001, ITB4002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ITB400CW
Basic UDI-DI: B-ITB400CW
Reference: ITB4001, ITB4002
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B & RSV RT-PCR Test Kit

IRP53Na

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IRP53NHJ
Basic UDI-DI: B-IRP53NHJ
Reference: IRP53Na
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae IgM Rapid Test

IMP4001, IMP4002

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsInstrumentKitMicrobial substancesSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IMP400DK
Basic UDI-DI: B-IMP400DK
Reference: IMP4001, IMP4002
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Leptospira IgG/IgM Rapid Test

ILEP4211, ILEP4212

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ILEP421XX
Basic UDI-DI: B-ILEP421XX
Reference: ILEP4211, ILEP4212
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 & Influenza A/B RT-PCR Test Kit

IID53Na

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IID53NBT
Basic UDI-DI: B-IID53NBT
Reference: IID53Na
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

HPV 18 High-Risk with 16/18 Genotyping PCR Test Kit

IHPVk0Ns

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IHPVk0NCQ
Basic UDI-DI: B-IHPVk0NCQ
Reference: IHPVk0Ns
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgG/IgM Rapid Test

IHAV4211, IHAV4212

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IHAV421W9
Basic UDI-DI: B-IHAV421W9
Reference: IHAV4211, IHAV4212
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test Cassette (Nasal Swab)

ICOVu002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICOVu00A4
Basic UDI-DI: B-ICOVu00A4
Reference: ICOVu002
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test Cassette (Saliva)

ICOV7002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICOV700Z9
Basic UDI-DI: B-ICOV700Z9
Reference: ICOV7002
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Nucleic Acid RT-PCR Test Kit

ICOV52Nb, ICOV52Na

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICOV52N32
Basic UDI-DI: B-ICOV52N32
Reference: ICOV52Nb, ICOV52Na
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details