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Fpfp Evk E-Cic R 440 Cbrn

by Widex A/S

Ref 8 406 0140 028Model CUSTOM

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

CE MDD

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
European UnionCE/MDD EUDAMED NumberB-05706069673210 Basic UDI-DI 05706069673210UDI-DIDate16 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05706069673210 UDI-DI Date30 Jul 2019ListedStatusListed GUDID: 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Fpfp Evk E-Cic R 440 Cbrn EUDAMED
Widex GUDID
Generic Name
Air-conduction hearing aid, canal
Model / Ref / Catalog
CUSTOM, 8 406 0140 028, E-CIC
Primary DI / UDI-DI
05706069673210
Basic UDI-DI
B-05706069673210
FDA Product Code
OSM
EMDN Code
Y2145060201 Hearing aid in the-ear (ite)
GMDN Term
Air-conduction hearing aid, canal
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3305
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
CUSTOM
8 406 0140 028
GUDID
E-CIC
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DK-MF-000025153

Other devices from Widex A/S

See all devices from Widex A/S →

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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