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COVID-19&Influenza A/B&RSV&ADV&MP&HMPV&HPIV Antigen combo Test
EUDAMEDClass B (EU MDR)
Ref A4D830Model Format (cassette): A4D83011 A4D830120 A4D830140 A4D83021 A4D830220 A4D830240
Identity
- Trade Name
- COVID-19&Influenza A/B&RSV&ADV&MP&HMPV&HPIV Antigen combo Test EUDAMED
- Device Name
- COVID-19&Influenza A/B&RSV&ADV&MP&HMPV&HPIV Antigen combo Test EUDAMED
- Model / Reference
- Format (cassette): A4D83011 A4D830120 A4D830140 A4D83021 A4D830220 A4D830240 EUDAMEDA4D830 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804833060 EUDAMED
- Basic UDI-DI
- 69528048A4D83007Q 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&HMPV&HPIV Antigen combo Test by Assure Tech. (hangzhou) Co., Ltd. — Class B — IVDR — listed in EUDAMED
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 | 69528048A4D83007Q | 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 98d592b7-975c-4174-be2a-2ed28953c9fd 61 fields · synced Jun 19, 2026