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Monkeypox Virus (MPxV) Antigen Rapid Detection Kit (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref SUPG290025
Identity
- Trade Name
- Monkeypox Virus (MPxV) Antigen Rapid Detection Kit (Colloidal Gold) EUDAMED
- Device Name
- Monkeypox Virus (MPxV) Antigen Rapid Detection Kit (Colloidal Gold) EUDAMED
- Model / Reference
- SUPG290025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521008071 EUDAMED
- Basic UDI-DI
- B-06974521008071 EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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
Monkeypox Virus (MPxV) Antigen Rapid Detection Kit (Colloidal Gold) by Shenzhen Superbio Technology 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-06974521008071 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Superbio Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024149
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 35a8b22b-eb8f-4f06-a35b-79f5c0107726 61 fields · synced Jun 18, 2026