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Breast cancer–associated gene mutation digital PCR detection kit
EUDAMEDClass IVD General (EU MDR)
Ref 12696--2Model BC01-Y12
Identity
- Trade Name
- Breast cancer–associated gene mutation digital PCR detection kit EUDAMED
- Device Name
- Breast cancer–associated gene mutation digital PCR detection kit EUDAMED
- Model / Reference
- BC01-Y12 EUDAMED12696--2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689627305 EUDAMED
- Basic UDI-DI
- B-06974689627305 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Breast cancer–associated gene mutation digital PCR detection kit by TargetingOne Technology (Beijing) Corporation — 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-06974689627305 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
- EUDAMED SRN
- CN-MF-000028247
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 9a76a0fe-4f78-4f90-be9f-1a6322e9f6f1 61 fields · synced Jul 19, 2026