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Lung cancer digital PCR panel plus
EUDAMEDClass IVD General (EU MDR)
Ref "Model: LC02-Q8, Specification: 8 Tests Model: LC02-Y8, Specification: 8 Tests"Model LC02-Q8,LC02-Y8Ref 12682-2Model LC01-Y12Ref 12683-1Model LC02-Q8Ref 12683-2Model LC02-Y8
Identity
- Trade Name
- Lung cancer digital PCR panel plus EUDAMEDLung cancer digital PCR panel EUDAMED
- Device Name
- Lung cancer digital PCR panel EUDAMEDLung cancer digital PCR panel plus EUDAMED
- Model / Reference
- LC02-Q8,LC02-Y8 EUDAMED"Model: LC02-Q8, Specification: 8 Tests Model: LC02-Y8, Specification: 8 Tests" EUDAMEDLC01-Y12 EUDAMED12682-2 EUDAMEDLC02-Q8 EUDAMED12683-1 EUDAMEDLC02-Y8 EUDAMED12683-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626223 EUDAMED06974689627176 EUDAMED06974689627169 EUDAMED
- Basic UDI-DI
- B-06974689626223 EUDAMEDB-06974689627176 EUDAMEDB-06974689627169 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
- Finland 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
Lung cancer digital PCR panel plus 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-06974689626223 | 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 (6)
- EUDAMED fec13cef-1ccb-46d3-9b10-6bda41888a59 61 fields · synced Jul 29, 2026
- EUDAMED fec13cef-1ccb-46d3-9b10-6bda41888a59-1 61 fields · synced Jun 9, 2026
- EUDAMED fec13cef-1ccb-46d3-9b10-6bda41888a59-2 61 fields · synced Jun 9, 2026
- EUDAMED 0b270f47-673c-4140-bf6b-8335343ecf7e 61 fields · synced Jul 9, 2026
- EUDAMED 202c3937-6af3-4933-b702-3ecee9d8c9e1 61 fields · synced Jul 12, 2026
- EUDAMED ec37ac74-0fc4-4dc8-a703-6744c5d7f11f 61 fields · synced Jul 29, 2026