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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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Monkeypox Virus Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-AMPV01FJ
Basic UDI-DI: B-AMPV01FJ
Reference: AMPV01-AOG48E, AMPV01-AOG96E, AMPV01D-AOG48E, AMPV01D-AOG96E
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA HHV6 Quantitative PCR Test

300157, 300184, 300673, 300180

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395SSAHHV6QTT4A
Basic UDI-DI: B-888501395SSAHHV6QTT4A
Reference: 300157, 300184, 300180, 300673
EMDN: W0105040524
EMDN description: HHV-6,7,8 - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CRTIZK0154ZG

CRTIZK01-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CRTIZK0154ZG
Basic UDI-DI: B-81649002CRTIZK0154ZG
Reference: CRTIZK01-AHG4E
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMPV01HGSL

AMPV01-AHG48E; AMPV01-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMPV01HGSL
Basic UDI-DI: B-81649002AMPV01HGSL
Reference: AMPV01-AHG48E; AMPV01-AHG96E
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMPV01DK32Z

AMPV01D-AHG48E; AMPV01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMPV01DK32Z
Basic UDI-DI: B-81649002AMPV01DK32Z
Reference: AMPV01D-AHG48E; AMPV01D-AHG96E
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002ADV01EQC5

ADV01-AHG48E; ADV01-AHG96E; ADV01D-AHG48E; ADV01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ADV01EQC5
Basic UDI-DI: B-81649002ADV01EQC5
Reference: ADV01-AHG48E; ADV01-AHG96E; ADV01D-AHG48E; ADV01D-AHG96E
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002ADV01DB5CX

ADV01D-AHG48E; ADV01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ADV01DB5CX
Basic UDI-DI: B-81649002ADV01DB5CX
Reference: ADV01D-AHG48E; ADV01D-AHG96E
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

BKIT VIRUS FINDER COVID-19 Saliva

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hyris Srl
Manufacturer SRN: IT-MF-000031635
UDI-DI: 80575074300852
Basic UDI-DI: B-80575074300852
Reference: bKTH-SCV2.04-72
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 12.07.2026 09:42

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BKIT VIRUS FINDER COVID-19 Saliva

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hyris Srl
Manufacturer SRN: IT-MF-000031635
UDI-DI: 80575074300784
Basic UDI-DI: B-80575074300784
Reference: bKTH-SCV2.04-32
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 12.07.2026 09:42

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BKIT VIRUS FINDER COVID-19

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hyris Srl
Manufacturer SRN: IT-MF-000031635
UDI-DI: 80575074300616
Basic UDI-DI: B-80575074300616
Reference: bKTH-SCV2.02-72
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 12.07.2026 09:42

Manufacturer products View details

BKIT VIRUS FINDER COVID-19

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hyris Srl
Manufacturer SRN: IT-MF-000031635
UDI-DI: 80575074300548
Basic UDI-DI: B-80575074300548
Reference: bKTH-SCV2.02-32
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 12.07.2026 09:42

Manufacturer products View details

ELISA-VIDITEST anti-HHV-6 IgG (CSF)