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Human PIK3CA Gene Mutation Fluorescence Diagnostic Kit (PCR-Fluorescence Probin…
EUDAMEDClass IVD General (EU MDR)
Ref S3063E
Identity
- Trade Name
- Human PIK3CA Gene Mutation Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Human PIK3CA Gene Mutation Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3063E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792733169 EUDAMED
- Basic UDI-DI
- B-06955792733169 EUDAMED
- EMDN Code
- W0106010114 PROTHROMBIN MUTATION EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Human PIK3CA Gene Mutation Fluorescence Diagnostic Kit (PCR-Fluorescence Probin… 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-06955792733169 | 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 (1)
- EUDAMED 2ec1633f-f296-484a-8e30-3131e4d61293 61 fields · synced Jun 19, 2026