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High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit (PCR-Fluorescence …
EUDAMEDClass IVD General (EU MDR)
Ref S3027E-48Ref S3027E-24
Identity
- Trade Name
- High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3027E-48 EUDAMEDS3027E-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792731073 EUDAMED06955792731059 EUDAMED
- Basic UDI-DI
- B-06955792731073 EUDAMEDB-06955792731059 EUDAMED
- EMDN Code
- W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS 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
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
High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit (PCR-Fluorescence … 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-06955792731073 | 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 (2)
- EUDAMED f019893b-5a48-4e29-a6e1-19d57710efb5 61 fields · synced Aug 2, 2026
- EUDAMED a17f6cc6-3967-403a-b9a4-0ffc63f1be00 61 fields · synced May 18, 2026