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KRAS/BRAF/NRAS/PIK3CA mutations digital PCR detection kit
EUDAMEDClass IVD General (EU MDR)
Ref "Model: KB01-Q12; Specification: 12 Tests Model: KB01-Y12; Specification: 12 Tests"Model KB01-Q12; B01-Y12Ref 12541-1Model KR01-Q24Ref 12541-2Model KR01-Y24
Identity
- Trade Name
- KRAS/BRAF/NRAS/PIK3CA mutations digital PCR detection kit EUDAMEDKRAS mutation digital PCR detection kit EUDAMED
- Device Name
- KRAS mutation digital PCR detection kit EUDAMED
- Model / Reference
- KB01-Q12; B01-Y12 EUDAMED"Model: KB01-Q12; Specification: 12 Tests Model: KB01-Y12; Specification: 12 Tests" EUDAMEDKR01-Q24 EUDAMED12541-1 EUDAMEDKR01-Y24 EUDAMED12541-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626063 EUDAMED06974689626582 EUDAMED06974689627312 EUDAMED
- Basic UDI-DI
- B-06974689626063 EUDAMEDB-06974689626582 EUDAMEDB-06974689627312 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMEDW01060202 K-RAS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMEDAustria 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
KRAS/BRAF/NRAS/PIK3CA mutations 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-06974689626063 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
- EUDAMED SRN
- CN-MF-000028247
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED 807f5e3a-8240-4106-bc63-f60573d2ac03 61 fields · synced Jul 28, 2026
- EUDAMED 807f5e3a-8240-4106-bc63-f60573d2ac03-1 61 fields · synced Jun 10, 2026
- EUDAMED 807f5e3a-8240-4106-bc63-f60573d2ac03-2 61 fields · synced Jun 10, 2026
- EUDAMED cd02ad22-8cf9-43aa-a99a-26211bc1ccf9 61 fields · synced Jun 18, 2026
- EUDAMED 21e48943-e95b-476c-87b9-447a772af021 61 fields · synced Jul 28, 2026