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Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)
EUDAMEDClass IVD General (EU MDR)
Ref S3355E-1Ref S3355E-50Ref S3355E-5Ref S3355E-25
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-1 EUDAMEDS3355E-50 EUDAMEDS3355E-5 EUDAMEDS3355E-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792730649 EUDAMED06955792730670 EUDAMED16955792730653 EUDAMED16955792730677 EUDAMED06955792730663 EUDAMED
- Basic UDI-DI
- B-06955792730649 EUDAMEDB-06955792730670 EUDAMEDB-16955792730653 EUDAMEDB-16955792730677 EUDAMEDB-06955792730663 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-06955792730649 | 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 (5)
- EUDAMED c84a5087-533e-4628-9165-4be8419be0ed 61 fields · synced Sep 17, 2026
- EUDAMED 37f4540e-1272-4358-97e2-786d2eea4b37 61 fields · synced May 17, 2026
- EUDAMED 5b30473e-970b-4ffd-adb5-b8f59bb48b28 61 fields · synced May 17, 2026
- EUDAMED b93994d4-6ddf-48f2-965d-2be1ab42e94d 61 fields · synced May 17, 2026
- EUDAMED 0e7d4172-2b0f-4673-a54f-97d786476364 61 fields · synced May 19, 2026