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Smartscope Pro retinal set 60100065A

by Optomed Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06430046260689 UDI-DI Date13 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Smartscope Pro retinal set
Generic Name
Multi-purpose digital medical camera
Model / Reference
60100065A
Primary DI / UDI-DI
06430046260689
510(k) Number
FDA Product Code
HKI
GMDN Term
Multi-purpose digital medical camera
Device Class
Class II
Regulation Number
886.1120
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K132186)

Other devices from Optomed Corp.

See all devices from Optomed Corp. →

Properties

  • Serial Number

Other properties (13)

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