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15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit (PCR-Fluoresc…
EUDAMEDClass IVD General (EU MDR)
Ref S3359E-12Ref S3031E
Identity
- Trade Name
- 15 High-risk Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- 15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED15 High-risk Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3359E-12 EUDAMEDS3031E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792743533 EUDAMED06955792731035 EUDAMED
- Basic UDI-DI
- B-06955792743533 EUDAMEDB-06955792731035 EUDAMED
- EMDN Code
- W0105041002 SCREENING HIGH-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMEDRomania 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
15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit (PCR-Fluoresc… 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-06955792743533 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- OSEN GmbH DE-AR-000023626
Sources (2)
- EUDAMED 69c81dd1-9831-4315-b34e-70742dd315e2 61 fields · synced Jul 15, 2026
- EUDAMED e40eaa20-3e82-462c-a6c0-f66684bec029 61 fields · synced May 19, 2026