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Kit Styletto 3X UK Blk Slv

by Signia GmbH

Ref 10970134Model SLIM RIC

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04063006009381 Basic UDI-DI 04063006009381UDI-DIDate18 Aug 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number04063006009381 UDI-DI Date17 Mar 2024ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Kit Styletto 3X UK Blk Slv EUDAMED
Signia GUDID
Generic Name
Air-conduction hearing aid, behind-the-ear
Model / Ref / Catalog
SLIM RIC, 10970134, Kit Styletto 3X
Primary DI / UDI-DI
04063006009381
Basic UDI-DI
B-04063006009381
FDA Product Code
OSM
EMDN Code
Y2145060102 Behind-the-ear hearing aids with receiver in the canal (ric, rite)
GMDN Term
Air-conduction hearing aid, behind-the-ear
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3305
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SLIM RIC
10970134
GUDID
Kit Styletto 3X
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000017173

Related devices

Category: Air-conduction hearing aid, receiver-in-canal

Other devices from Signia GmbH

See all devices from Signia GmbH →

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No