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Rotavirus/Adenovirus Antigen Combo Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref RAV-F22a
Identity
- Trade Name
- Rotavirus/Adenovirus Antigen Combo Rapid Test EUDAMED
- Device Name
- Rotavirus/Adenovirus Antigen Combo Rapid Test EUDAMED
- Model / Reference
- RAV-F22a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-RAV-F22aKD EUDAMED
- Basic UDI-DI
- B-RAV-F22aKD EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Rotavirus/Adenovirus Antigen Combo Rapid Test by Hangzhou Aichek Medical Technology 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-RAV-F22aKD | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED fd6f20f9-f7e5-4901-89db-8c4880c00109 61 fields · synced Jul 10, 2026