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Microclear FC-01

by Suzhou Microclear Medical Instruments Co., Ltd.

Microclear FC-01 is a Class II device made by Suzhou Microclear Medical Instruments Co., Ltd., listed in FDA GUDID since 27 Jan 2021 (UDI-DI 06970990160043), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06970990160043 UDI-DI Date27 Jan 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  • Withdrawn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
Microclear
Generic name
Ophthalmic fundus camera
Model / reference
FC-01
Primary DI / UDI-DI
06970990160043
FDA product code
PJZ
GMDN term
Ophthalmic fundus camera
Device class
Class II
Regulation number
886.1120
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic fundus camera

Similar devices in this category

Other devices filed under Ophthalmic fundus camera.

Other devices from Suzhou Microclear Medical Instruments Co., Ltd.

See all devices from Suzhou Microclear Medical Instruments Co., Ltd. →

Properties

  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)