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1096 Madsen Zodiac

by Natus Medical Denmark ApS FDA registration: Denmark EUDAMED

Ref 8-04-16350Model 8-04-16030 EMDN Z12149005

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5713315NA001024Z Basic UDI-DIDate18 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
1096 Zodiac PC Quick Check (US only)
Model / Reference
8-04-16030, 8-04-16350
Primary DI / UDI-DI
05713315009891
Basic UDI-DI
5713315NA001024Z
EMDN Code
Z12149005 Impedance meters for the auditory system
Device Class
Class IIa
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000001617

Other devices from Natus Medical Denmark ApS

See all devices from Natus Medical Denmark ApS →

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 05713315009891|5713315NA001024Z 61 fields · synced 24 Oct 2026