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Ha Bicore R312 60 Sb

by Wsaud a/S EUDAMEDGUDID

Active European Union

Ref 21002365Model 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 Number05714880156492 UDI-DIDate11 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  • Withdrawn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
Ha Bicore R312 60 Sb EUDAMED
Rexton GUDID
Generic Name
Air-conduction hearing aid, receiver-in-canal
Model / Ref / Catalog
RIC, 21002365, BiCore RIC312 60
Primary DI / UDI-DI
05714880156492
Basic UDI-DI
5714880-WSA-26-15-3Z
FDA Product Code
ESD, KLW
EMDN Code
Y2145060102 Behind-the-ear hearing aids with receiver in the canal (ric, rite)
GMDN Term
Air-conduction hearing aid, receiver-in-canal
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
874.3300, 874.3400
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
RIC
21002365
GUDID
BiCore RIC312 60
Device ClassEUDAMED
Class IIa
GUDID
Class I

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