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Otoscopes

by Hangzhou Hawk Optical Electronic Instruments Co., Ltd. China EUDAMED

Ref T0123Model RJ EMDN Z12021007

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69470146RJ00057410SW Basic UDI-DIDate26 Jan 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  • Withdrawn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 · synced 25 Oct 2026

Device Name
Otoscopes
Model / Reference
RJ, T0123
Primary DI / UDI-DI
06947014603107
Basic UDI-DI
69470146RJ00057410SW
EMDN Code
Z12021007 Middle ear otoscopes
Device Class
Class I
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
CN-MF-000028791
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Hangzhou Hawk Optical Electronic Instruments Co., Ltd.

See all devices from Hangzhou Hawk Optical Electronic Instruments Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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 06947014603107|69470146RJ00057410SW 61 fields · synced 25 Oct 2026