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GN ReSound SN7CIC-HP

by Gn Hearing A/S

Part of a family of 336 devices: see the family page

Ref SN7CIC-HPModel ITC

GN ReSound SN7CIC-HP is a device classified as Class IIa in the EU and Class II in the US made by Gn Hearing A/S, registered in EUDAMED on 14 Aug 2026 (Basic UDI-DI 57082960000613F) and listed in FDA GUDID since 10 Feb 2026 (UDI-DI 05708296383764), active as of 2 Nov 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57082960000613F Basic UDI-DI 05708296383764UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05708296383764 UDI-DI Date10 Feb 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 57082960000613F registered 14 Aug 2026 Active
  • FDA GUDID UDI-DI 05708296383764 listed 10 Feb 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05708296383764
  2. Registered EUDAMED 57082960000613F

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  • Withdrawn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
GN ReSound
Generic name
Air-conduction hearing aid, canal
Model / reference
SN7CIC-HP, ITC
Primary DI / UDI-DI
05708296383764
Basic UDI-DI
57082960000613F
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 registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC).

Other devices from Gn Hearing A/S

See all devices from Gn Hearing A/S →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)