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Multiple Real-Time PCR kit for Detection of SARS-CoV-2
EUDAMEDClass IVD General (EU MDR)
Ref 48Tests/kit
Identity
- Device Name
- Multiple Real-Time PCR kit for Detection of SARS-CoV-2 EUDAMED
- Model / Reference
- 48Tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970664750396 EUDAMED
- Basic UDI-DI
- B-06970664750396 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Multiple Real-Time PCR kit for Detection of SARS-CoV-2 by Beijing Kewei Clinical Diagnostic Reagent Inc — 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-06970664750396 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Kewei Clinical Diagnostic Reagent Inc
- EUDAMED SRN
- CN-MF-000019125
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 60074e9b-0d57-478d-9586-9d19e0f5ace6 61 fields · synced Jul 26, 2026