BioFire® Respiratory Panel 2.1 plus (RP2.1 plus)
by BioFire Diagnostics, LLC United States EUDAMED
Ref 423740
EMDN W0105070503
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number357302BUDI000002SE | Date1 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
EU market availability
Available in 30 countries, as listed in EUDAMED:
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
Certificates
- IVDR 799673 Issued
Technical documentation EU IVDR
- Notified body
- Notified body 2797
- Issued
- 3 Aug 2026
- Expires
- 2 Aug 2031
Specification
- Model / Reference
- 423740
- Primary DI / UDI-DI
- 00815381020505
- Basic UDI-DI
- 357302BUDI000002SE
- EMDN Code
- W0105070503 Respiratory tract infections - multiplex na reagents
- Device Class
- Class D
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- US-MF-000003311
- Authorised representative
- bioMérieux SA FR-AR-000004435
Other devices from BioFire Diagnostics, LLC
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 7d47cae3-a6c4-40ce-9069-d4d8b099c6ad