Pts
by Sorin Group Italia S.r.L. 1,000+ variants
Ref AB4604
Pts (AB4604) is a medical device (EU MDD Class IIa; EMDN category extracorporeal circulation circuits) made by Sorin Group Italia S.R.L, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-08033178388931), active as of 7 Nov 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08033178388931 08033178388931 | Date5 Nov 2026 | StatusActive |
Official records
- EUDAMED public site B-08033178388931
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Mdd Pts
- Model / reference
- AB4604
- Primary DI / UDI-DI
- 08033178388931
- Basic UDI-DI
- B-08033178388931
- EMDN code
- C03010101 Extracorporeal circulation circuits
- Device class
- Class IIa
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000027510
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