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ampli-mini I 2 5P CIC-10 NWL PH

by Sonova AG

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

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 13 Oct 2026. What this means

Regulatory status

as of registry sync 13 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07613389772845 UDI-DI Date12 Nov 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Air-conduction hearing aid, in-the-ear
Model / Ref / Catalog
10 NWL PH, 063-0533-0167
Primary DI / UDI-DI
07613389772845
FDA Product Code
KLW, ESD
GMDN Term
Air-conduction hearing aid, in-the-ear
Device Class
Class II
Regulation Number
874.3400, 874.3300
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Air-conduction hearing aid, in-the-ear

Other devices from Sonova AG

See all devices from Sonova AG →

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing 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
  • Lot / Batch Number: No
  • Expiration Date: No