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Essilor SL400H

by Shanghai Mediworks Precision Instruments Co., Ltd.

Essilor SL400H is a Class II device made by Shanghai Mediworks Precision Instruments Co., Ltd., listed in FDA GUDID since 10 May 2021 (UDI-DI 06945087540015), registry data as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06945087540015 UDI-DI Date10 May 2021ListedStatusListed 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  • Withdrawn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
Essilor
Generic name
Ophthalmic examination slit lamp
Model / reference
SL400H
Primary DI / UDI-DI
06945087540015
FDA product code
HJO
GMDN term
Ophthalmic examination slit lamp
Device class
Class II
Regulation number
886.1850
GUDID distribution status
In Commercial Distribution

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Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)