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Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo)
EUDAMEDClass IVD General (EU MDR)
Ref FCRA-6052
Identity
- Trade Name
- Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo) EUDAMED
- Device Name
- Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo) EUDAMED
- Model / Reference
- FCRA-6052 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974246461076 EUDAMED
- Basic UDI-DI
- B-06974246461076 EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo) by Safecare Biotech (Hangzhou) 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-06974246461076 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Safecare Biotech (hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000019109
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 3ac7873c-c672-479d-8cb2-0ea7ef34c5df 61 fields · synced Jun 18, 2026