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Oscilla® A30 w. H210A headset

by Oscilla A/S Denmark EUDAMEDGUDID

Ref 1231Model ATM4 Product code EWOEMDN Z121401

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05745000311163 UDI-DIDate29 May 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number5745000311ATM4TW Basic UDI-DIDate4 May 2023RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Oscilla® A30 w. H210A headset EUDAMED
Oscilla GUDID
Generic Name
Tone audiometer
Device Name
Oscilla Audiometer
Model / Ref / Catalog
ATM4, 1231, Oscilla® A30 w. H210A headset
Primary DI / UDI-DI
05745000311163
Basic UDI-DI
5745000311ATM4TW
Direct Marketing DI
05745000311163
FDA Product Code
EWO
EMDN Code
Z121401 Audiometers
GMDN Term
Tone audiometer
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.1050
Market of Registration
Denmark
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ATM4
1231
GUDID
Oscilla® A30 w. H210A headset
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DK-MF-000002784

From the manufacturer

Manufacturer's product page: A30 Audiometer

Other devices from Oscilla A/S

See all devices from Oscilla A/S →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date
Other properties (20)
  • 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

Sources (2)

  • EUDAMED 5d77f3fd-fa8c-4ce2-b370-0cdd7c88ab31 61 fields · synced 22 Oct 2026
  • FDA UDI c28d7705-e22e-4315-a21d-2b1c391e7498 35 fields · synced 22 Oct 2026