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Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)
EUDAMEDClass C (EU MDR)
Ref S3057E-48Ref S3054E
Identity
- Trade Name
- Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing) EUDAMEDHigh-risk Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing) EUDAMEDHigh-risk Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3057E-48 EUDAMEDS3054E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792731523 EUDAMED06955792731936 EUDAMED
- Basic UDI-DI
- 69557927S3057E000001SS EUDAMEDB-06955792731936 EUDAMED
- EMDN Code
- W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS EUDAMEDW0105041002 SCREENING HIGH-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- France 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
New Device
No
EUDAMED
Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing) by Sansure Biotech Inc. — Class C — IVDD, IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69557927S3057E000001SS | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 69557927S3057E000001SS | Class C | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 160792d5-5820-4659-b74a-0e8692ab07a9 61 fields · synced Jul 14, 2026
- EUDAMED 736fdc75-eea3-4a61-bc07-1fc66b17c304 61 fields · synced May 17, 2026