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Ha Cros-Fs USA Hnbl

by Wsaud a/S Denmark EUDAMEDGUDID

Ref 10998037Model RIC Product code OSMEMDN Y214599

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5714880-WSA-62-15-49 Basic UDI-DIDate11 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05706069876260 UDI-DIDate11 Jan 2024ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Ha Cros-Fs USA Hnbl EUDAMED
Widex GUDID
Generic Name
Air-conduction hearing aid, behind-the-ear
Model / Ref / Catalog
RIC, 10998037, CROS-FS BTE
Primary DI / UDI-DI
05706069876260
Basic UDI-DI
5714880-WSA-62-15-49
FDA Product Code
OSM, KLW
EMDN Code
Y214599 Hearing aids - other
GMDN Term
Air-conduction hearing aid, behind-the-ear
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
874.3305, 874.3400
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
RIC
10998037
GUDID
CROS-FS BTE
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
DK-MF-000015974

Other devices from Wsaud a/S

See all devices from Wsaud a/S →

Properties & raw data

Show properties, registry sources and raw records
  • Premarket Exempt
  • Serial Number
Other properties (22)
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED 1fde3f11-8863-4c92-8a0e-6e917ac2ffda 61 fields · synced 22 Oct 2026
  • FDA UDI c3612cb8-a7bc-4bdd-9614-f3dacb10c8d1 35 fields · synced 30 May 2026