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Monkeypox virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
EUDAMEDClass IVD General (EU MDR)
Ref S3352E-24-PRef S3352E-48Ref S3352E-12-P
Identity
- Device Name
- Monkeypox virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3352E-24-P EUDAMEDS3352E-48 EUDAMEDS3352E-12-P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792731509 EUDAMED06955792731493 EUDAMED06955792731486 EUDAMED
- Basic UDI-DI
- B-06955792731509 EUDAMEDB-06955792731493 EUDAMEDB-06955792731486 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMEDPortugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) 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-06955792731509 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 2107864f-aec7-4bb9-985a-eecd6250ba7a 61 fields · synced Aug 1, 2026
- EUDAMED a020d05c-9a87-4a2c-a314-f9c3aabf1556 61 fields · synced May 18, 2026
- EUDAMED 53b8d710-73e0-4d00-b93c-e008f265e92a 61 fields · synced May 19, 2026