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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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228 device results listed.

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Access HBs Ag

IVD Annex II List AIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A24291TY
Basic UDI-DI: B-A24291TY
Reference: A24291
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBc Ab

IVD Annex II List AIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34240FZ
Basic UDI-DI: B-34240FZ
Reference: 34240
EMDN: W0105020202
EMDN description: HEPATITIS B SURFACE ANTIGEN - CONFIRMATORY
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access HAV IgM (Reagent Pack)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34210FQ
Basic UDI-DI: B-34210FQ
Reference: 34210
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

HAV Ab (Reagent pack)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34200FM
Basic UDI-DI: B-34200FM
Reference: 34200
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

MP Diagnostics HCV ELISA 4.0

IVD Annex II List ANot specifiedOn the market

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000498
Basic UDI-DI: B-08887581000498
Reference: 23130-096
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 10.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorion

Fluorion HDV QNP 1.0 Real-Time PCR Kit

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
Manufacturer SRN: TR-MF-000023054
UDI-DI: 08698898740621
Basic UDI-DI: B-08698898740621
Reference: M0060202
EMDN: W0105020406
EMDN description: HEPATITIS DELTA VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 15:00

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Fluorion

Fluorion HCV QNP 2.1 Real-Time PCR

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
Manufacturer SRN: TR-MF-000023054
UDI-DI: 08698898740027
Basic UDI-DI: B-08698898740027
Reference: M0020202
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 14:59

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Fluorion

Fluorion HBV QNP 2.0 Real-Time PCR Kit

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
Manufacturer SRN: TR-MF-000023054
UDI-DI: 08698898740010
Basic UDI-DI: B-08698898740010
Reference: M0010202
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 14:59

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SOFTEC Hepatitis E Virus (HEV) IgG/IgM Rapid Test Kit

SFHEV40

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616282
Basic UDI-DI: B-08697962616282
Reference: SFHEV
EMDN: W0105020503
EMDN description: HEV ANTIBODY (TOTAL)
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

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LyoSens HCV Detection qPCR Kit

LYO79

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034910
Basic UDI-DI: B-08684595034910
Reference: LYO79
EMDN: W0105020399
EMDN description: HCV REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:16

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LyoSens HBV Detection qPCR Kit

LYO78

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034897
Basic UDI-DI: B-08684595034897
Reference: LYO78
EMDN: W0105020299
EMDN description: HBV REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:16

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RapidFor™ HBsAb Rapid Test Kit (FIA)

VMPO88

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030233
Basic UDI-DI: B-08684595030233
Reference: VMPO88
EMDN: W0105020217
EMDN description: HEPATITIS B SURFACE ANTIGEN - QUANTITATIVE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:13

Manufacturer products View details

RevoDx HCV qPCR Kit