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1096 Madsen Zodiac

by Natus Medical Denmark ApS 10 variants

Ref 8-04-16339Model 8-04-16030

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5713315NA001024Z Basic UDI-DI 05713315009785UDI-DIDate18 Feb 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
1096 Zodiac PC Quick Check (US only)
Model / Reference
8-04-16030, 8-04-16339
Primary DI / UDI-DI
05713315009785
Basic UDI-DI
5713315NA001024Z
EMDN Code
Z12149005 Impedance meters for the auditory system
Device Class
Class IIa
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000001617

Related devices

Category: Impedance audiometer

Other devices from Natus Medical Denmark ApS

See all devices from Natus Medical Denmark ApS →

Properties

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