Skip to content

Tympa Otoscope System (Samsung A40)

by Tympa Health Technologies Ltd EUDAMED

Active European Union

Ref THA4002

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506075352GEN2OTOAB Basic UDI-DIDate4 Jun 2024RegisteredStatusActive

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  • Withdrawn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

Device Name
Tympa Otoscope System
Model / Reference
THA4002
Primary DI / UDI-DI
15060753520035
Basic UDI-DI
506075352GEN2OTOAB
Direct Marketing DI
15060753520035
EMDN Code
Z12149006 Direct outpatient otoscopes
Device Class
Class I
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
UK-MF-000042174
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Tympa Health Technologies Ltd

See all devices from Tympa Health Technologies Ltd →

Properties

Show 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