Gap
by Alfamed SRL
Ref GA6035
Gap (GA6035) is a Class IIa device made by Alfamed SRL, registered in EUDAMED on 14 May 2026 (Basic UDI-DI B-08056479540211), active as of 24 Oct 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-08056479540211 08056479540211 | Date14 May 2026 | StatusActive |
Official records
- EUDAMED public site B-08056479540211
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Gap
- Model / reference
- GA6035
- Primary DI / UDI-DI
- 08056479540211
- Basic UDI-DI
- B-08056479540211
- EMDN code
- N02010101 Epiduroscopy and epiduroplastics catheters and kits
- Device class
- Class IIa
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000033580
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