← Back to catalogue
COVID-19 Coronavirus and Influenza A/B Virus Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref JC10310NW-50TRef JC10310NW-25T
Identity
- Trade Name
- COVID-19 Coronavirus and Influenza A/B Virus Real Time PCR Kit EUDAMED
- Device Name
- COVID-19 Coronavirus and Influenza A/B Virus Real Time PCR Kit EUDAMED
- Model / Reference
- JC10310NW-50T EUDAMEDJC10310NW-25T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-JC10310NW-50TNW EUDAMEDD-JC10310NW-25TNW EUDAMED
- Basic UDI-DI
- B-JC10310NW-50TNW EUDAMEDB-JC10310NW-25TNW EUDAMED
- EMDN Code
- W0105040519 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
COVID-19 Coronavirus and Influenza A/B Virus Real Time PCR Kit by Jiangsu Bioperfectus Technologies 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-JC10310NW-50TNW | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000014691
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED fabd0f85-72f0-4c2e-a922-9249d57a44d4 61 fields · synced Oct 6, 2026
- EUDAMED 804a0c35-3c9d-454e-922b-e26b3af391d8 61 fields · synced May 18, 2026