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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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Determine Syphilis TP

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingSingle use

Manufacturer: Abbott Diagnostics Medical Co., Ltd.
Manufacturer SRN: JP-MF-000009543
UDI-DI: 04571226470206
Basic UDI-DI: B-04571226470206
Reference: 7D2443
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Netherlands
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

04562185405323

TRCReady SARS-CoV-2 NE

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185405323
Basic UDI-DI: B-04562185405323
Reference: 0056110
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

04562185395303

TRCReady MTB

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185395303
Basic UDI-DI: B-04562185395303
Reference: 0056101
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

04560189216426

CL AIA-PACK SARS-CoV-2-Ag CONTROL SET

IVD generalIVDDNo longer on the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189216426
Basic UDI-DI: B-04560189216426
Reference: 0029374
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:48

Manufacturer products Authorised representative products Authorised representative actors View details

04560189216419

CL AIA-PACK SARS-CoV-2-Ag SAMPLE TREATMENT SOLUTION

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189216419
Basic UDI-DI: B-04560189216419
Reference: 0029574
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:48

Manufacturer products Authorised representative products Authorised representative actors View details

04560189216303

CL AIA-PACK SARS-CoV-2-Ab CONTROL SET

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189216303
Basic UDI-DI: B-04560189216303
Reference: 0029710
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656979
Basic UDI-DI: B-00810173656979
Reference: 2RET9A01
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656986
Basic UDI-DI: B-00810173656986
Reference: 2RYT8A01
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

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Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656948
Basic UDI-DI: B-00810173656948
Reference: 2HPV29A01
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 01.08.2026 10:40

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Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656931
Basic UDI-DI: B-00810173656931
Reference: 2HPV18A01
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 01.08.2026 10:40

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Aspergillus fumigatus IgG ELISA