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Wide-field Ophthalmic Imaging System SK-8000C

by ChongQing SunKingdom Medical Instrument Co., Ltd. EUDAMED

Active European Union

Ref SK-8000CModel SK-8000A, SK-8000B, SK-8000C

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69732110710OS8T Basic UDI-DIDate16 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Wide-field Ophthalmic Imaging System
Model / Reference
SK-8000A, SK-8000B, SK-8000C
Primary DI / UDI-DI
06973211071494
Basic UDI-DI
69732110710OS8T
Direct Marketing DI
06973211071494
EMDN Code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000014351
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

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