Hyrespira 5-in-1 Rapid Test
by Heyer Medical AG Germany EUDAMED
Ref 140003Model Multiple Models EMDN W0105099099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number4251743800016UW | Date29 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- EU-QMS-FI-88700-800168-2026 Issued
Quality management system EU IVDR
- Notified body
- Notified body 3018
- Issued
- 14 Jul 2026
- Expires
- 14 Jul 2031
- EU-TDA-FI-92091-800168-2026 Issued
Technical documentation EU IVDR
- Notified body
- Notified body 3018
- Issued
- 14 Jul 2026
- Expires
- 14 Jul 2031
Specification
- Device Name
- SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)
- Model / Reference
- Multiple Models, 140003
- Primary DI / UDI-DI
- 04251743800549
- Basic UDI-DI
- 4251743800016UW
- EMDN Code
- W0105099099 Virology - rt & poc - other
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000014330
Other devices from Heyer Medical AG
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED d559ce17-eb1e-4733-8acd-d040d809a187