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medicalprint shell beige 2.0 1000g 03016

by DETAX GmbH

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEDET030161 UDI-DI Date25 Feb 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  • Withdrawn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
medicalprint shell beige 2.0 1000g
Generic Name
Earmould, custom-made
Model / Reference
03016
Primary DI / UDI-DI
EDET030161
FDA Product Code
ESD
GMDN Term
Earmould, custom-made
Device Class
Class I
Regulation Number
874.3300
GUDID distribution status
In Commercial Distribution

Other devices from DETAX GmbH

See all devices from DETAX GmbH →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • 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
  • Serial Number: No
  • Manufacturing Date: No