Skip to content

Eli Ezer ERK-770

by U.S. Ophthalmic, L.L.C.

Eli Ezer ERK-770 is a Class I device made by U.S. Ophthalmic, L.L.C., listed in FDA GUDID since 29 Oct 2026 (UDI-DI 00850038195649), registry data as of 9 Nov 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850038195649 UDI-DI Date29 Oct 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Eli Ezer
Generic name
Automated ophthalmic refractometer
Model / reference
ERK-770
Primary DI / UDI-DI
00850038195649
FDA product code
HKO
GMDN term
Automated ophthalmic refractometer
Device class
Class I
Regulation number
886.1760
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code HKO (Refractometer, Ophthalmic).

Other devices from U.S. Ophthalmic, L.L.C.

See all devices from U.S. Ophthalmic, L.L.C. →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)