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Tyto Otoscope Adaptor

by Tyto Care Ltd. 3 variants

Ref 800-00009Model Tyto Otoscope Ear Specula

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number07290016672OTOSS4 Basic UDI-DI 07290016672824UDI-DIDate28 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Tyto Otoscope
Model / Reference
Tyto Otoscope Ear Specula, 800-00009
Primary DI / UDI-DI
07290016672824
Basic UDI-DI
07290016672OTOSS4
EMDN Code
Z12149006 Direct outpatient otoscopes
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IL-MF-000010611
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Tyto Care Ltd

See all devices from Tyto Care Ltd →

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