← Back to catalogue
Human PIK3CA Gene Mutation Detection Kit (Fluorometric PCR)
EUDAMEDClass IVD General (EU MDR)
Ref ID018
Identity
- Device Name
- Human PIK3CA Gene Mutation Detection Kit (Fluorometric PCR) EUDAMED
- Model / Reference
- ID018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323012870 EUDAMED
- Basic UDI-DI
- B-06974323012870 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Human PIK3CA Gene Mutation Detection Kit (Fluorometric PCR) by Beijing Applied Biological Technologies Co., Ltd. — 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-06974323012870 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 8eeaeae9-5933-425b-a607-06c21714402b 61 fields · synced Jul 11, 2026