← Back to catalogue
StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detecti…
EUDAMEDClass IVD General (EU MDR)
Ref 500190Model 96 Tests/box
Identity
- Trade Name
- StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes) EUDAMED
- Device Name
- Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes) EUDAMED
- Model / Reference
- 96 Tests/box EUDAMED500190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973181850143 EUDAMED
- Basic UDI-DI
- B-06973181850143 EUDAMED
- EMDN Code
- W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detecti… by Nanjing Liming Bio-products Co. Ltd — Class IVD General — IVDD — listed in…
Manufacturer's product page: Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time P...
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-06973181850143 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nanjing Liming Bio-products Co. Ltd
- EUDAMED SRN
- CN-MF-000041298
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED c93e547c-b5f6-45bd-b484-ddf66e545278 61 fields · synced Jun 18, 2026