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EGFR mutations digital PCR detection kit
EUDAMEDClass IVD General (EU MDR)
Ref Model: EG02-Q16; Specification: 16 Tests Model: EG02-Y16; Specification: 16 TestsRef 12517-1Model EG02-Q16Ref 12517-2Model EG02-Y16
Identity
- Trade Name
- EGFR mutations digital PCR detection kit EUDAMED
- Device Name
- EGFR mutations digital PCR detection kit EUDAMED
- Model / Reference
- Model: EG02-Q16; Specification: 16 Tests Model: EG02-Y16; Specification: 16 Tests EUDAMEDEG02-Q16 EUDAMED12517-1 EUDAMEDEG02-Y16 EUDAMED12517-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626049 EUDAMED06974689627039 EUDAMED
- Basic UDI-DI
- B-06974689626049 EUDAMEDB-06974689627039 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
- Netherlands 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
EGFR 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-06974689626049 | 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 (4)
- EUDAMED 96612308-3457-4836-9197-4779d7703a59 61 fields · synced Jun 20, 2026
- EUDAMED 96612308-3457-4836-9197-4779d7703a59-1 61 fields · synced Jun 10, 2026
- EUDAMED e751aaf2-6570-4147-adad-4da77cabcede 61 fields · synced Jun 20, 2026
- EUDAMED ca4c57aa-b647-43ab-a6ab-6417eb7f5368 61 fields · synced Jun 20, 2026