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Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 G…
EUDAMEDClass IVD General (EU MDR)
Ref RR-0479-02-50
Identity
- Trade Name
- Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 Genes) EUDAMED
- Device Name
- Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 Genes) EUDAMED
- Model / Reference
- RR-0479-02-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042229565 EUDAMED
- Basic UDI-DI
- B-06971042229565 EUDAMED
- EMDN Code
- W0105040519 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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) Real Time Multiplex RT-PCR Kit (Detection for 3 G… by Shanghai Zj Bio-Tech Co., Ltd. — 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-06971042229565 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shanghai Zj Bio-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000017861
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED de19ea62-525c-4161-b371-0d57518358be 61 fields · synced Jun 18, 2026