← Back to catalogue
Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref RR-0496-02-25Ref RR-0508-02-48B
Identity
- Trade Name
- Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit EUDAMEDNovel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 2 Genes) EUDAMED
- Device Name
- Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit EUDAMEDNovel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 2 Genes) EUDAMED
- Model / Reference
- RR-0496-02-25 EUDAMEDRR-0508-02-48B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042228483 EUDAMED06971042229602 EUDAMED
- Basic UDI-DI
- B-06971042228483 EUDAMEDB-06971042229602 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 by Shanghai Zj Bio-Tech Co., Ltd. — 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-06971042228483 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai Zj Bio-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000017861
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 62525486-fc0a-47d9-bbd7-13310e8d2b4b 61 fields · synced Jul 11, 2026
- EUDAMED 3288dd37-387f-4dbc-9300-7c4652b41f31 61 fields · synced May 17, 2026