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TargetingOne
EUDAMEDClass IVD General (EU MDR)
Ref EG01-Q24、EG01-Y24Model EG01-Q24、EG01-Y24Ref 12507-1Model EG01-Q24
Identity
- Trade Name
- TargetingOne EUDAMEDEGFR Ex19Del/L858R/T790M mutations digital PCR detection kit EUDAMED
- Device Name
- EGFR Ex19Del/L858R/T790M mutations digital PCR detection kit EUDAMED
- Model / Reference
- EG01-Q24、EG01-Y24 EUDAMEDEG01-Q24 EUDAMED12507-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626032 EUDAMED
- Basic UDI-DI
- B-06974689626032 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMEDW01060299 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
TargetingOne by TargetingOne Technology (Beijing) Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06974689626032 | 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 (2)
- EUDAMED a88b9986-82ce-41b5-b163-5a45bae3d9f0 61 fields · synced Jul 30, 2026
- EUDAMED ba84c629-649a-4f28-b1fa-a48485526d06 61 fields · synced Jun 14, 2026