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Philips 246136

by Sbo Hearing A/S

Philips 246136 is a Class II device made by Sbo Hearing A/S, listed in FDA GUDID since 10 Aug 2022 (UDI-DI 05714464060023), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05714464060023 UDI-DI Date10 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Philips
Generic name
Hearing aid wireless-fitting computer-aided set
Model / reference
246136
Primary DI / UDI-DI
05714464060023
FDA product code
KLW, OSM
GMDN term
Hearing aid wireless-fitting computer-aided set
Device class
Class II
Regulation number
874.3400, 874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code KLW (Masker, tinnitus).

Other devices from Sbo Hearing A/S

  • Gpl

    Class IIa
  • Amplifon

    Class IIa
  • Hhm

    Class IIa
  • ViO

    Class IIa

See all devices from Sbo Hearing A/S →

Properties

  • Premarket exempt
Other properties (14, all answered No)