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RetCam 3

by Clarity Medical Systems

Listed FDA GUDID listing, not in commercial distribution

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 1 Jun 2026. What this means

Regulatory status

as of registry sync 1 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00899281002113 UDI-DI Date19 Dec 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Ophthalmic fundus camera
Model / Reference
RetCam 3
Primary DI / UDI-DI
00899281002113
FDA Product Code
HKI
GMDN Term
Ophthalmic fundus camera
Device Class
Class II
Regulation Number
886.1120
GUDID distribution status
Not in Commercial Distribution

Other devices from Clarity Medical Systems

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No