Pts
by Sorin Group Italia S.r.L. United States EUDAMED
Ref IN02860H
EMDN C03010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08033178397995 | Date10 Jun 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- IN02860H Fi Oulu
- Model / Reference
- IN02860H
- Primary DI / UDI-DI
- 08033178397995
- Basic UDI-DI
- B-08033178397995
- EMDN Code
- C03010101 Extracorporeal circulation circuits
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000027510
Other devices from Sorin Group Italia S.R.L
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED e7cfd146-58d5-48a3-bae0-97eddd5c0ab1