← Back to catalogue
Monkeypox Virus Antigen Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref W-MV-01Model 1 test/kit
Identity
- Trade Name
- Monkeypox Virus Antigen Rapid Test Kit EUDAMED
- Device Name
- Monkeypox Virus Antigen Rapid Test Kit EUDAMED
- Model / Reference
- 1 test/kit EUDAMEDW-MV-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973720139821 EUDAMED
- Basic UDI-DI
- B-06973720139821 EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
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 Antigen Rapid Test Kit by Wuhan Easydiagnosis Biomedicine Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06973720139821 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 9f862e94-aa67-4e66-bfb5-cc2c7b0c02f1 61 fields · synced Oct 6, 2026