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Human Monkeypox Virus (MPV) Antigen Rapid Test Device (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref K771616DModel k771616D
Identity
- Trade Name
- Human Monkeypox Virus (MPV) Antigen Rapid Test Device (Colloidal Gold) EUDAMED
- Model / Reference
- k771616D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792050884 EUDAMED
- Basic UDI-DI
- B-06971792050884 EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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 Realy Tech 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-06971792050884 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED e998103a-c05d-4954-90c2-9b91ed9a9372 61 fields · synced Jun 18, 2026