Skip to content

C_ite Insio C&G 1AX Itc

by Wsaud a/S EUDAMEDGUDID

Active European Union

Ref 21006357Model CUSTOM

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5714880-WSA-26-25-46 Basic UDI-DIDate11 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05714880129496 UDI-DIDate15 Feb 2023ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
C_ite Insio C&G 1AX Itc EUDAMED
Signia GUDID
Generic Name
Air-conduction hearing aid, in-the-ear
Model / Ref / Catalog
CUSTOM, 21006357, Insio C&G 1AX ITC
Primary DI / UDI-DI
05714880129496
Basic UDI-DI
5714880-WSA-26-25-46
FDA Product Code
OSM
EMDN Code
Y2145060202 Hearing aids in-the-canal (itc)
GMDN Term
Air-conduction hearing aid, in-the-ear
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3305
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
CUSTOM
21006357
GUDID
Insio C&G 1AX ITC
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DK-MF-000015974

Other devices from Wsaud a/S

See all devices from Wsaud a/S →

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