← Back to catalogue
Human EGFR, KRAS, BRAF, NRAS, PIK3CA Gene Mutation Joint Detection Kit (Combina…
EUDAMEDClass IVD General (EU MDR)
Ref USCI-JK001Ref USCI-RJ001Ref ID016
Identity
- Device Name
- Human EGFR, KRAS, BRAF, NRAS, PIK3CA Gene Mutation Joint Detection Kit (Combinatorial Probe Anchor Synthesis) EUDAMEDHuman EGFR, KRAS, BRAF, NRAS, PIK3CA Gene Mutation Joint Detection Kit Analysis Software EUDAMEDHuman KRAS/NRAS/BRAF Gene Mutation Joint Detection Kit (Fluorometric PCR) EUDAMED
- Model / Reference
- USCI-JK001 EUDAMEDUSCI-RJ001 EUDAMEDID016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CN-MF-000026308SG EUDAMEDD-CN-MF-000026308-RJ001UD EUDAMED06974323012849 EUDAMED
- Basic UDI-DI
- B-CN-MF-000026308SG EUDAMEDB-CN-MF-000026308-RJ001UD EUDAMEDB-06974323012849 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMEDW02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMEDEUDAMED
Surgical Instrument
No
EUDAMED
Human EGFR, KRAS, BRAF, NRAS, PIK3CA Gene Mutation Joint Detection Kit (Combina… by Beijing USCI Medical Devices Co., Ltd. — Class IVD General — IVDD — listed…
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-CN-MF-000026308SG | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing USCI Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000026308
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (3)
- EUDAMED 865730cc-c401-4966-b4a9-5bdd0551f024 61 fields · synced Oct 6, 2026
- EUDAMED 8b052509-8953-4455-a945-efd1a04dc19b 61 fields · synced May 17, 2026
- EUDAMED 87d7ff2f-011e-4500-a8a6-7fa714aeb774 61 fields · synced Jul 18, 2026