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PIK3CA 11 Mutations Digital PCR Assay
EUDAMEDClass IVD General (EU MDR)
Ref 3.02.03.0005Model 24 Tests
Identity
- Trade Name
- PIK3CA 11 Mutations Digital PCR Assay EUDAMED
- Device Name
- PIK3CA 11 Mutations Digital PCR Assay EUDAMED
- Model / Reference
- 24 Tests EUDAMED3.02.03.0005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975760470186 EUDAMED
- Basic UDI-DI
- B-06975760470186 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
PIK3CA 11 Mutations Digital PCR Assay by Suzhou Precigenome Ltd, Co; — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06975760470186 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Suzhou Precigenome Ltd, Co;
- EUDAMED SRN
- CN-MF-000024105
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED b110803f-da92-4575-acf7-a18c20eb06df 61 fields · synced Jun 18, 2026