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Audioprosthesis TAP 07.78.650

by Audio Technologies SRL

Listed FDA GUDID listing, no authorization on record

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 Number08057143543026 UDI-DI Date3 Sep 2026ListedStatusListed GUDID: 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  • Withdrawn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
Audioprosthesis
Generic Name
Ossicular prosthesis, partial
Model / Ref / Catalog
TAP 07.78.650
Primary DI / UDI-DI
08057143543026
510(k) Number
FDA Product Code
ETB
GMDN Term
Ossicular prosthesis, partial
Device Class
Class II
Regulation Number
874.3450
GUDID distribution status
In Commercial Distribution
Size
Length — 6.50 Millimeter

Related devices

Cleared under the same submission (K001142)

Other devices from Audio Technologies SRL

  • Duramesh Lyo

    Class III

  • Native 3D

    Class III

  • Braxon

    Class III

  • Native

    Class III

  • Braxon Fast

    Class III

  • Otosurgery prostheses

    Class IIb

See all devices from Audio Technologies SRL →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No