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SARS-CoV-2 Antigen Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref XC25103
Identity
- Device Name
- SARS-CoV-2 Antigen Rapid Test Kit EUDAMED
- Model / Reference
- XC25103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937044500774 EUDAMED
- Basic UDI-DI
- B-06937044500774 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 Antigen Rapid Test Kit by Ningbo HEALTH Gene Technologies 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-06937044500774 | 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 (1)
- EUDAMED 3452c541-9d34-43f5-bfc4-5b0e0b25a9be 61 fields · synced Jul 8, 2026