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Instrumentation Difra SA

by Instrumentation Difra SA

Instrumentation Difra SA (19141) is a Class I device made by Instrumentation Difra SA, listed in FDA GUDID since 2 Jul 2026 (UDI-DI B516191410), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB516191410 UDI-DI Date2 Jul 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  • Withdrawn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

Generic name
Ear speculum, single-use
Model / Ref / Catalog
Silicone tips, water caloric stimulator, 2mm inner diameter (50 pieces), 19141
Primary DI / UDI-DI
B516191410
FDA product code
JYK
GMDN term
Ear speculum, single-use
Device class
Class I
Regulation number
878.1800
GUDID distribution status
In Commercial Distribution

Other devices from S.A. Instrumentation Difra

See all devices from S.A. Instrumentation Difra →

Properties

  • Single use
  • Contains latex
  • Premarket exempt
  • Serial number
Other properties (11, all answered No)