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SensiScreen
EUDAMEDClass IVD General (EU MDR)
Ref 5585; 5586; 5587; 5590; 5591; 5592; 5600; 5601Model PIK3CA qPCR Assay
Identity
- Trade Name
- SensiScreen EUDAMED
- Device Name
- SensiScreen® Liquid PIK3CA qPCR Assay EUDAMED
- Model / Reference
- PIK3CA qPCR Assay EUDAMED5585; 5586; 5587; 5590; 5591; 5592; 5600; 5601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5713915SS010V4Q3 EUDAMED
- Basic UDI-DI
- B-5713915SS010V4Q3 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Denmark 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
SensiScreen by PentaBase A/S — 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-5713915SS010V4Q3 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PentaBase A/S
- EUDAMED SRN
- DK-MF-000023157
Sources (2)
- EUDAMED 0d0d8bb4-2b72-434a-a2d9-4403af6dfdb6 61 fields · synced Aug 1, 2026
- EUDAMED 0d0d8bb4-2b72-434a-a2d9-4403af6dfdb6-1 61 fields · synced Jun 10, 2026