← Back to catalogue
COVID-19/Flu/RSV/ADV/MP Antigen Combo Rapid Test(Swab)
EUDAMEDClass IVD General (EU MDR)
Ref FCRAM-6062
Identity
- Trade Name
- COVID-19/Flu/RSV/ADV/MP Antigen Combo Rapid Test(Swab) EUDAMED
- Device Name
- COVID-19/Flu/RSV/ADV/MP Antigen Combo Rapid Test(Swab) EUDAMED
- Model / Reference
- FCRAM-6062 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697424646FCRAM6062HHMF EUDAMED
- Basic UDI-DI
- B-697424646FCRAM6062HHMF EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
COVID-19/Flu/RSV/ADV/MP Antigen Combo Rapid Test(Swab) 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-697424646FCRAM6062HHMF | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Safecare Biotech (hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000019109
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 43fc36cc-276c-4dee-a549-d1a466ce5f5e 61 fields · synced Aug 4, 2026