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COVID-19 Antigen Rapid Test
EUDAMEDClass B (EU MDR)
Ref Format (cassette): A47915; Format (pen): A48410Model Format (cassette): A4791511 A47915120 A47915140 A4791521 A47915220 A47915240 Format (pen): A4841011 A48410120 A4841021 A48410220
Identity
- Trade Name
- COVID-19 Antigen Rapid Test EUDAMED
- Device Name
- COVID-19 Antigen Rapid Test EUDAMED
- Model / Reference
- Format (cassette): A4791511 A47915120 A47915140 A4791521 A47915220 A47915240 Format (pen): A4841011 A48410120 A4841021 A48410220 EUDAMEDFormat (cassette): A47915; Format (pen): A48410 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804832087 EUDAMED
- Basic UDI-DI
- 69528048A4791503Y EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER 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
COVID-19 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 | 69528048A4791503Y | 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 (2)
- EUDAMED ace02bb8-fc78-40fd-abf5-41f26820b054 61 fields · synced Jun 18, 2026
- EUDAMED ace02bb8-fc78-40fd-abf5-41f26820b054-1 61 fields · synced Jun 10, 2026