Auroflex Ev Gold
Ref NilModel HP760APY
Auroflex Ev Gold (Nil) is a Class IIb device made by Aurolab, registered in EUDAMED on 15 Oct 2026 (Basic UDI-DI B-803878HPY0019D7D), 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-803878HPY0019D7D D-803878HPY0019D7D | Date15 Oct 2026 | StatusActive |
Official records
- EUDAMED public site B-803878HPY0019D7D
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Preloaded Yellow Hydrophobic Foldable Intraocular Lenses
- Model / reference
- HP760APY, Nil
- Primary DI / UDI-DI
- D-803878HPY0019D7D
- Basic UDI-DI
- B-803878HPY0019D7D
- EMDN code
- P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
- Device class
- Class IIb
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- IN-MF-000007255
- Authorised representative
- mdi Europa GmbH DE-AR-000006218
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