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Rha RHA2020/2020-U

by Annidis Health Systems Corp.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00627843652021 UDI-DI Date5 Aug 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Rha
Generic Name
Direct ophthalmoscope, line-powered
Model / Reference
RHA2020/2020-U
Primary DI / UDI-DI
00627843652021
510(k) Number
FDA Product Code
HKI, HLI
GMDN Term
Direct ophthalmoscope, line-powered
Device Class
Class II
Regulation Number
886.1120, 886.1570
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Safe

Other devices from Annidis Health Systems Corp.

  • RHA2020

    Class II

Properties

  • Combination Product
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No