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Set Bicore Cros R312 Bg

by Wsaud a/S EUDAMEDGUDID

Active European Union

Ref 21002382Model RIC

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5714880-WSA-26-15-3Z Basic UDI-DIDate7 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05714880156621 UDI-DIDate15 Sep 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  • Withdrawn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
Set Bicore Cros R312 Bg EUDAMED
Rexton GUDID
Generic Name
Contralateral hearing unit
Model / Ref / Catalog
RIC, 21002382, BiCore CROS R312
Primary DI / UDI-DI
05714880156621
Basic UDI-DI
5714880-WSA-26-15-3Z
FDA Product Code
OSM, KLW
EMDN Code
Y2145060102 Behind-the-ear hearing aids with receiver in the canal (ric, rite)
GMDN Term
Contralateral hearing unit
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3305, 874.3400
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
RIC
21002382
GUDID
BiCore CROS R312
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DK-MF-000015974

Related devices

Category: Air-conduction hearing aid, receiver-in-canal

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