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Monkeypox Virus（MPxV）Antigen Rapid Detection Kit （Immunochromatography Assay）
EUDAMEDClass IVD General (EU MDR)
Ref SUPL030025
Identity
- Trade Name
- Monkeypox Virus（MPxV）Antigen Rapid Detection Kit （Immunochromatography Assay） EUDAMED
- Device Name
- Monkeypox Virus（MPxV）Antigen Rapid Detection Kit （Immunochromatography Assay） EUDAMED
- Model / Reference
- SUPL030025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521001812 EUDAMED
- Basic UDI-DI
- B-06974521001812 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - 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
Yes
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 （Immunochromatography Assay） by Shenzhen Superbio Technology Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974521001812 | 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 4805a75b-eb7a-47af-9269-baba43696b5a 61 fields · synced Jun 20, 2026