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Novel coronavirus (2019-nCoV) nucleic acid detection kit (Fluorescent PCR metho…
EUDAMEDClass IVD General (EU MDR)
Ref Specification: 24Test/Box
Identity
- Trade Name
- Novel coronavirus (2019-nCoV) nucleic acid detection kit (Fluorescent PCR method) EUDAMED
- Model / Reference
- Specification: 24Test/Box EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626292 EUDAMED
- Basic UDI-DI
- B-06974689626292 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland 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
Novel coronavirus (2019-nCoV) nucleic acid detection kit (Fluorescent PCR metho… by TargetingOne Technology (Beijing) Corporation — Class IVD General — IVDD…
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-06974689626292 | 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 e02e8070-0c11-4a7a-8d73-facba16ef9dc 61 fields · synced Jun 18, 2026