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Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)
EUDAMEDClass IVD General (EU MDR)
Ref S3357E-1Ref S3357E-25Ref Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)Model S3357E-50Ref S3357E-5
Identity
- Trade Name
- Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method) EUDAMED
- Device Name
- Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method) EUDAMED
- Model / Reference
- S3357E-1 EUDAMEDS3357E-25 EUDAMEDS3357E-50 EUDAMEDMonkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method) EUDAMEDS3357E-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792730687 EUDAMED16955792730707 EUDAMED06955792730717 EUDAMED16955792730691 EUDAMED06955792730694 EUDAMED06955792730700 EUDAMED16955792730684 EUDAMED
- Basic UDI-DI
- B-06955792730687 EUDAMEDB-16955792730707 EUDAMEDB-06955792730717 EUDAMEDB-16955792730691 EUDAMEDB-06955792730694 EUDAMEDB-06955792730700 EUDAMEDB-16955792730684 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
Yes
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 Antibody 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-06955792730687 | 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 (7)
- EUDAMED da9da85c-6f9b-4d4b-81eb-5d7cf9b62c9a 61 fields · synced Aug 2, 2026
- EUDAMED a4b37625-7a8a-4c09-bdae-53f3ace73cd8 61 fields · synced May 16, 2026
- EUDAMED 28281c27-6c51-4a38-aed9-11d8214fdcc9 61 fields · synced May 17, 2026
- EUDAMED 6fe1bbdb-45f0-462e-a05f-f5ca2c544857 61 fields · synced May 18, 2026
- EUDAMED 06d52f93-6635-4f20-849b-a26a795ab305 61 fields · synced May 18, 2026
- EUDAMED b7af42c1-0b93-49d3-aa79-8113abd30c4c 61 fields · synced May 19, 2026
- EUDAMED 3aaacfd7-d92b-4f5d-9e30-3ca9daf29c61 61 fields · synced May 19, 2026