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Vision Screener

by Tianjin Suowei Electronic Technology Co., Ltd China EUDAMED

Ref SW-800

EMDN Z1212012001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697241391SW-800GB Basic UDI-DIDate13 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Vision Screener
Model / Reference
SW-800
Primary DI / UDI-DI
06972413910044
Basic UDI-DI
697241391SW-800GB
EMDN Code
Z1212012001 Visual functional assessment equipment
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000030245
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Tianjin Suowei Electronic Technology Co., Ltd

See all devices from Tianjin Suowei Electronic Technology Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
  • Measuring Function
Other properties (11)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 0b441103-7b6f-4e9f-8df7-65661dea5584 61 fields · synced 22 Oct 2026