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SARS-CoV-2 Virus Detection Diagnostic Kit (RT-qPCR Method)
EUDAMEDClass IVD General (EU MDR)
Ref XC25073Ref XC25079
Identity
- Device Name
- SARS-CoV-2 Virus Detection Diagnostic Kit (RT-qPCR Method) EUDAMED
- Model / Reference
- XC25073 EUDAMEDXC25079 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937044500811 EUDAMED06937044500781 EUDAMED
- Basic UDI-DI
- B-06937044500811 EUDAMEDB-06937044500781 EUDAMED
- EMDN Code
- W0105040519 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2 Virus Detection Diagnostic Kit (RT-qPCR Method) by Ningbo HEALTH Gene 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-06937044500811 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ningbo HEALTH Gene Technologies Co., LTD.
- EUDAMED SRN
- CN-MF-000002278
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED ccaa05fb-e29c-46ee-a480-2058089bb345 61 fields · synced Jul 30, 2026
- EUDAMED 8b6dee71-3411-4c0d-864e-4ca1db7b22a8 61 fields · synced May 18, 2026