hasa optix
Ref IP85161 x10
hasa optix (IP85161 x10) is a Class IIa device made by Hasa Optix, registered in EUDAMED on 23 Oct 2023 (Basic UDI-DI B-05404027448305), 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-05404027448305 05404027448305 | Date23 Oct 2023 | StatusActive |
Official records
- EUDAMED public site B-05404027448305
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- IP85161 x10: Sterile, Single Use, PRK SET OERTLI
- Model / reference
- IP85161 x10
- Primary DI / UDI-DI
- 05404027448305
- Basic UDI-DI
- B-05404027448305
- EMDN code
- Q021113 Ophthalmic surgery instrument kits, single-use
- Device class
- Class IIa
- System or procedure pack
- Procedure pack which is a device in itself
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- BE-MF-000028219
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