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by The Top Hands Ltd. Taiwan EUDAMED

Ref 3016Model SEE Reading Glasses

EMDN Q0210030103

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471996436RG-SEEMK Basic UDI-DIDate16 Apr 2026RegisteredStatusActive

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
SEE Voltaire
Model / Reference
SEE Reading Glasses, 3016
Primary DI / UDI-DI
05400323330160, 05400323301665, 05400323301627, 05400323301641, 05400323430167
Basic UDI-DI
471996436RG-SEEMK
EMDN Code
Q0210030103 Ready to wear metal and plastic spectacles with organic lenses
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
TW-MF-000053055
Authorised representative
Trannex SA BE-AR-000051602

Other devices from The Top Hands Ltd.

  • See

    Class I

  • See

    Class I

  • See

    Class I

  • See

    Class I

  • See

    Class I

  • See

    Class I

See all devices from The Top Hands 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 (5)

  • EUDAMED 03dd8f0e-1fbc-4bfc-8b68-3085244151d4 61 fields · synced 23 Oct 2026
  • EUDAMED 05400323301665|471996436RG-SEEMK 61 fields · synced 19 Jun 2026
  • EUDAMED 05400323301627|471996436RG-SEEMK 61 fields · synced 19 Jun 2026
  • EUDAMED 05400323301641|471996436RG-SEEMK 61 fields · synced 12 Jul 2026
  • EUDAMED 05400323430167|471996436RG-SEEMK 61 fields · synced 6 Oct 2026