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Oscilla® A60 w. DD65 headset

by Oscilla A/S Denmark EUDAMED

Ref 1237Model ATM4

EMDN Z121401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5745000311ATM4TW Basic UDI-DIDate4 May 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Oscilla Audiometer
Model / Reference
ATM4, 1237
Primary DI / UDI-DI
05745000311194
Basic UDI-DI
5745000311ATM4TW
Direct Marketing DI
05745000311194
EMDN Code
Z121401 Audiometers
Device Class
Class IIa
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000002784

From the manufacturer

Manufacturer's product page: A60 Audiometer

Other devices from Oscilla A/S

See all devices from Oscilla A/S →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: 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

Sources (1)

  • EUDAMED b7194e17-cddc-47f6-81d8-1a86c491f615 61 fields · synced 22 Oct 2026