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Microtech Signature Series 12 Cic Nw

by Starkey Laboratories Inc.

Ref P00004222Model Custom

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00840388202395 UDI-DI Date25 Jun 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08423181P000044 Basic UDI-DI 00840388202395UDI-DIDate3 May 2024RegisteredStatusActive

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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Microtech Signature Series 12 Cic Nw EUDAMED
Microtech GUDID
Generic Name
Air-conduction hearing aid, canal
Device Name
Signature Series
Model / Reference
Custom EUDAMED
P00004222 EUDAMED
MICROTECH SIGNATURE SERIES 12 CIC NW GUDID
Primary DI / UDI-DI
00840388202395
Basic UDI-DI
08423181P000044
FDA Product Code
KLW, ESD
EMDN Code
Y2145060203 Hearing aids completely-in-the-canal (cic)
GMDN Term
Air-conduction hearing aid, canal
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3400, 874.3300
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Custom
P00004222
GUDID
MICROTECH SIGNATURE SERIES 12 CIC NW
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000014382
Authorised representative
Starkey Laboratories (Germany) GmbH DE-AR-000010831

Other devices from Starkey Laboratories Inc.

See all devices from Starkey Laboratories Inc. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

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