← Back to catalogue
c-MET Exon 14 Skipping RT-qPCR Test
EUDAMEDClass IVD General (EU MDR)
Ref EU001A01Model 24 tests /kit
Identity
- Device Name
- c-MET Exon 14 Skipping RT-qPCR Test EUDAMED
- Model / Reference
- 24 tests /kit EUDAMEDEU001A01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975296640497 EUDAMED
- Basic UDI-DI
- B-06975296640497 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
c-MET Exon 14 Skipping RT-qPCR Test by MEDx (Suzhou) Translational Medicine 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-06975296640497 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MEDx (Suzhou) Translational Medicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000028603
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 319e8654-d3e7-43ee-98c2-358367a37851 61 fields · synced Oct 9, 2026