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Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP)
EUDAMEDClass IVD General (EU MDR)
Ref S3362E-24Ref S3362E-48
Identity
- Trade Name
- Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP) EUDAMED
- Device Name
- Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP) EUDAMED
- Model / Reference
- S3362E-24 EUDAMEDS3362E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16955792730721 EUDAMED06955792730724 EUDAMED16955792730738 EUDAMED
- Basic UDI-DI
- B-16955792730721 EUDAMEDB-06955792730724 EUDAMEDB-16955792730738 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
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 DNA Fluorescence Diagnostic Kit (LAMP) by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-16955792730721 | 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 (3)
- EUDAMED aba34629-f953-42f2-b3b4-c9a47775342d 61 fields · synced Jul 13, 2026
- EUDAMED aff122f5-be18-44d8-845d-1fd3e3b897e1 61 fields · synced May 17, 2026
- EUDAMED 740deca0-5ed4-4512-8f90-2326a891e8f1 61 fields · synced May 17, 2026