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Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)
EUDAMEDClass IVD General (EU MDR)
Ref S3355E-5
Identity
- Trade Name
- Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method) EUDAMED
- Device Name
- Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method) EUDAMED
- Model / Reference
- S3355E-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792730656 EUDAMED
- Basic UDI-DI
- B-06955792730656 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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 (MPV) Rapid Antigen Test Kit (Colloidal Gold Method) by Sansure Biotech Inc. — 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-06955792730656 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED e64e4871-1e36-42e3-af5d-615b47caac88 61 fields · synced Jun 17, 2026