Skip to content

OMNI Surgical System

by Sight Sciences, Inc.

Ref 1-109

OMNI Surgical System (1-109) is a Class IIa device made by Sight Sciences, Inc., registered in EUDAMED on 31 Aug 2023 (Basic UDI-DI 08580270061001LA), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08580270061001LA Basic UDI-DI 00858027006532UDI-DIDate31 Aug 2023RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
1-109
Primary DI / UDI-DI
00858027006532
Basic UDI-DI
08580270061001LA
EMDN code
Q021199 Ophthalmic surgery instruments, single-use - other
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000008813
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Sight Sciences, Inc.

See all devices from Sight Sciences, Inc. →

Properties

  • Supplied sterile
Other properties (13, all answered No)