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Adenovirus Antigen Nasal Rapid Test
EUDAMEDClass B (EU MDR)
Ref A464101Model A46410120, A46410220
Identity
- Trade Name
- Adenovirus Antigen Nasal Rapid Test EUDAMED
- Device Name
- Adenovirus Antigen Nasal Rapid Test EUDAMED
- Model / Reference
- A46410120, A46410220 EUDAMEDA464101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804832032 EUDAMED
- Basic UDI-DI
- 69528048A46410023 EUDAMED
- EMDN Code
- W0105040601 ADENOVIRUS 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
Adenovirus Antigen Nasal 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 | 69528048A46410023 | 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 d8cf3ad5-fc5c-4b53-83ca-c3cc4c879ad5 61 fields · synced Jul 27, 2026