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Human Monkeypox Virus (MPV) Antigen Rapid Test Device (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref A051601D
Identity
- Trade Name
- Human Monkeypox Virus (MPV) Antigen Rapid Test Device (Colloidal Gold) EUDAMED
- Model / Reference
- A051601D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976753476055 EUDAMED
- Basic UDI-DI
- B-06976753476055 EUDAMED
- EMDN Code
- W0102080399 ANTIBIOTICS TDM - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
Human Monkeypox Virus (MPV) Antigen Rapid Test Device (Colloidal Gold) by Hangzhou Cybereagen Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06976753476055 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Cybereagen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000037850
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED f25fb6eb-9f69-41d6-89d4-1b71f55967be 61 fields · synced Aug 1, 2026