FLU A&B/ COVID-19 Combo Pen Home Test
by Azubio Diagnostics Co., Ltd EUDAMED
Active
Ref A47660H11Model Pen
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697945273A47660HBV | Date20 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Certificates
- 6188356TD02 Active
Technical documentation EU IVDR
- Notified body
- 0344
- Issued
- 6 Aug 2026
- Expires
- 1 Aug 2031
- 6188356CE02 Active
Quality management system EU IVDR
- Notified body
- 0344
- Issued
- 6 Aug 2026
- Expires
- 1 Jan 2031
- Reason
- Add device or group
Specification
- Device Name
- FLU A&B/ COVID-19 Combo Pen Home Test
- Model / Reference
- Pen, A47660H11
- Primary DI / UDI-DI
- 06979452730374
- Basic UDI-DI
- 697945273A47660HBV
- EMDN Code
- W0105090601 Coronavirus / influenza - rt & poc
- Device Class
- Class C
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000032581
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Azubio Diagnostics Co., Ltd
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No