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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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587 device results listed.

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00810173655187

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173655187
Basic UDI-DI: 81649002Mplex-M100RS
Reference: M-FLA-202-01
EMDN: W02020499
EMDN description: FLOW CYTOMETRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 08.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette)

GCHCV-302a

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028482
Basic UDI-DI: B-00816490028482
Reference: GCHCV-302a
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette)

GCHCV-402a

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028475
Basic UDI-DI: B-00816490028475
Reference: GCHCV-402a
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

Hand-Held Immunofluorescence

OG-G300

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028444
Basic UDI-DI: 81649002OG-G3008A
Reference: OG-G300
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

Immunofluorescence Analyzer

OG-G200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028437
Basic UDI-DI: 81649002OG-G20085
Reference: OG-G200
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

Mini Immunofluorescence Analyzer

OG-H100

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028420
Basic UDI-DI: 81649002OG-H10087
Reference: OG-H100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

Immunofluorescence Analyzer

OG-H180

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028192
Basic UDI-DI: 81649002OG-H1808X
Reference: OG-H180
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details