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COVID-19&Influenza A/B&RSV&ADV&MP Antigen combo Test
EUDAMEDClass B (EU MDR)
Ref Format (cassette): A49230;Format (pen): A4D560Model Format (cassette): A4923011 A49230120 A49230140 A4923021 A49230220 A49230240 Format (pen): A4D56011 A4D560120 A4D56021 A4D560220
Identity
- Trade Name
- COVID-19&Influenza A/B&RSV&ADV&MP Antigen combo Test EUDAMED
- Device Name
- COVID-19&Influenza A/B&RSV&ADV&MP Antigen combo Test EUDAMED
- Model / Reference
- Format (cassette): A4923011 A49230120 A49230140 A4923021 A49230220 A49230240 Format (pen): A4D56011 A4D560120 A4D56021 A4D560220 EUDAMEDFormat (cassette): A49230;Format (pen): A4D560 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804832285 EUDAMED
- Basic UDI-DI
- 69528048A4923002Y EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC 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&Influenza A/B&RSV&ADV&MP Antigen combo 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 | 69528048A4923002Y | 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 (3)
- EUDAMED 76cb8394-63aa-4c3b-80e3-c113057822c7 61 fields · synced Jun 18, 2026
- EUDAMED 76cb8394-63aa-4c3b-80e3-c113057822c7-1 61 fields · synced Jun 9, 2026
- EUDAMED 76cb8394-63aa-4c3b-80e3-c113057822c7-2 61 fields · synced Jun 9, 2026