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Monkeypox Virus Detection Kit (Fluorescence PCR)

EUDAMED

Class IVD General (EU MDR)

Ref AMPV01-AOG48E, AMPV01-AOG96E, AMPV01D-AOG48E, AMPV01D-AOG96ERef AMPV01-AOG48E; AMPV01-AOG96E

by Zhejiang Orient Gene Biotech Co., Ltd

Identity

Trade Name
Monkeypox Virus Detection Kit (Fluorescence PCR) EUDAMED
Device Name
Monkeypox Virus Detection Kit (Fluorescence PCR) EUDAMED
Model / Reference
AMPV01-AOG48E, AMPV01-AOG96E, AMPV01D-AOG48E, AMPV01D-AOG96E EUDAMED
AMPV01-AOG48E; AMPV01-AOG96E EUDAMED

Identifiers

Primary DI / UDI-DI
D-AMPV01FJ EUDAMED
D-69509960AMPV01UYBQ EUDAMED
Basic UDI-DI
B-AMPV01FJ EUDAMED
B-69509960AMPV01UYBQ EUDAMED
EMDN Code
W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMED
W0105040532 MONKEYPOX VIRUS / MPOX - NA REAGENT EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
France EUDAMED
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMEDEUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Monkeypox Virus Detection Kit (Fluorescence PCR) by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
EUDAMED SRN
CN-MF-000017965
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (3)

  • EUDAMED 5a9eebc0-7f25-4078-a8c7-efce3f24656d 61 fields · synced Oct 6, 2026
  • EUDAMED 5a9eebc0-7f25-4078-a8c7-efce3f24656d-1 61 fields · synced Jun 10, 2026
  • EUDAMED 96a03076-f74d-4abb-8713-085c6a639550-1 61 fields · synced Jul 9, 2026