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Ophthalmic Wide Field Imaging System

by Tianjin Suowei Electronic Technology Co., Ltd China EUDAMED

Ref SW-8000P EMDN Q0299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697241391OWFIS001CW Basic UDI-DIDate9 Feb 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  • Withdrawn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 22 Oct 2026

Device Name
Ophthalmic Wide Field Imaging System
Model / Reference
SW-8000P
Primary DI / UDI-DI
06972413910006
Basic UDI-DI
697241391OWFIS001CW
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000030245
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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
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 1339c139-dcab-4421-b6de-0bec6609c421 61 fields · synced 22 Oct 2026