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ALK/ROS1/MET gene fusions and mutations digital PCR detection kit
EUDAMEDClass IVD General (EU MDR)
Ref 12605-2Model AR01-Y16
Identity
- Trade Name
- ALK/ROS1/MET gene fusions and mutations digital PCR detection kit EUDAMED
- Device Name
- ALK/ROS1/MET gene fusions and mutations digital PCR detection kit EUDAMED
- Model / Reference
- AR01-Y16 EUDAMED12605-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689627121 EUDAMED
- Basic UDI-DI
- B-06974689627121 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
ALK/ROS1/MET gene fusions and mutations digital PCR detection kit by TargetingOne Technology (Beijing) Corporation — Class IVD General — IVDD — listed in…
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-06974689627121 | 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 (1)
- EUDAMED f9e87951-905e-451f-bb5d-044b597f646d 61 fields · synced Jun 19, 2026