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Rosen Round Ear Specula 3mm ESP0203

by Dtr Medical Limited

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

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 Number05060212050274 UDI-DI Date11 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Rosen Round Ear Specula 3mm
Generic Name
Ear speculum, single-use
Model / Reference
ESP0203
Primary DI / UDI-DI
05060212050274
FDA Product Code
EPY
GMDN Term
Ear speculum, single-use
Device Class
Class I
Regulation Number
878.1800
GUDID distribution status
In Commercial Distribution

Other devices from Dtr Medical Limited

See all devices from Dtr Medical Limited →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No