← Back to catalogue
Influenza Virus A&B Real Time RT-PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref RR-0097-02Ref RR-0488-02-50Ref RR-0488-02-25
Identity
- Trade Name
- Influenza Virus A&B Real Time RT-PCR Kit EUDAMEDNovel Coronavirus (2019-nCoV) and Influenza Virus A&B Real Time RT-PCR Kit EUDAMED
- Device Name
- Influenza Virus A&B Real Time RT-PCR Kit EUDAMEDNovel Coronavirus (2019-nCoV) and Influenza Virus A&B Real Time RT-PCR Kit EUDAMED
- Model / Reference
- RR-0097-02 EUDAMEDRR-0488-02-50 EUDAMEDRR-0488-02-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042227882 EUDAMED06971042228452 EUDAMED06971042228438 EUDAMED
- Basic UDI-DI
- B-06971042227882 EUDAMEDB-06971042228452 EUDAMEDB-06971042228438 EUDAMED
- EMDN Code
- W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS EUDAMEDW0105040519 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
Influenza Virus A&B Real Time RT-PCR Kit by Shanghai Zj Bio-Tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06971042227882 | 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 (3)
- EUDAMED dd5f8457-dff6-4860-839b-1da19c581237 61 fields · synced Jul 18, 2026
- EUDAMED dbfebd67-0914-48fd-b0f1-9123fe517714 61 fields · synced May 17, 2026
- EUDAMED 4b11baf1-eddd-4808-9954-663bc65559cf 61 fields · synced May 18, 2026