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C_ite Insio 2NX Itc/Hs

by Signia GmbH EUDAMEDGUDID

Active European Union

Ref 10986219Model CUSTOM

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04063006013388 Basic UDI-DIDate15 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04063006013388 UDI-DIDate17 Mar 2024ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD 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 2NX Itc/Hs EUDAMED
Signia GUDID
Generic Name
Air-conduction hearing aid, in-the-ear
Model / Ref / Catalog
CUSTOM, 10986219, Insio 2Nx ITC
Primary DI / UDI-DI
04063006013388
Basic UDI-DI
B-04063006013388
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
10986219
GUDID
Insio 2Nx ITC
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000017173

Other devices from Signia GmbH

See all devices from Signia GmbH →

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