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Rotavirus Antigen Rapid Test
EUDAMEDClass B (EU MDR)
Ref A49930Model A49930125, A49930225
Identity
- Trade Name
- Rotavirus Antigen Rapid Test EUDAMED
- Device Name
- Rotavirus Antigen Rapid Test EUDAMED
- Model / Reference
- A49930125, A49930225 EUDAMEDA49930 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804800680 EUDAMED
- Basic UDI-DI
- 69528048A4993004H EUDAMED
- EMDN Code
- W0105040606 ROTAVIRUS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Rotavirus Antigen Rapid Test by Assure Tech. (hangzhou) Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69528048A4993004H | Class B | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED f028fb1e-060a-4a3a-ba05-068fc5def700 61 fields · synced Jul 9, 2026