Skip to content

1076 Aurical Otocam 300

by Natus Medical Denmark ApS FDA registration: Denmark EUDAMED

Ref 8-62-42710Model Otocam EMDN Z12021009

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5713315NA0003153 Basic UDI-DIDate15 Oct 2025RegisteredStatusActive

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  • Withdrawn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
1076 Aurical Otocam 300
Model / Reference
Otocam, 8-62-42710
Primary DI / UDI-DI
05713315008580
Basic UDI-DI
5713315NA0003153
EMDN Code
Z12021009 Direct outpatient video-otoscopes
Device Class
Class I
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
  • Reprocessed
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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 69ca4bfe-0c99-41f7-907d-828fd03389ab 61 fields · synced 24 Oct 2026