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Tympa Otoscope System

by Tympa Health Technologies Ltd United Kingdom EUDAMED

Ref THANDA

EMDN Z12149006

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Tympa Otoscope System
Model / Reference
THANDA
Primary DI / UDI-DI
25060753520087
Basic UDI-DI
506075352GEN2OTOAB
Direct Marketing DI
25060753520087
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 & 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 3a0d760f-fc19-407b-ae64-14b3b568495b 61 fields · synced 23 Oct 2026