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Ophthalmic Optical Coherence Tomography System

by Guangdong Weiren Meditech Co., Ltd EUDAMED

Active European Union

Ref Velite C2000Model Velite C3000, Velite C3000B, Velite C3000C, Velite C2000, Velite C1000, Velite C800A, Velite C800B

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697481859WR0001TC Basic UDI-DIDate4 Mar 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Velite C3000, Velite C3000B, Velite C3000C, Velite C2000, Velite C1000, Velite C800A, Velite C800B
Primary DI / UDI-DI
06974818590098
Basic UDI-DI
697481859WR0001TC
Direct Marketing DI
06974818590098
EMDN Code
Z12120121 Optical consistency tomographs
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000017166
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Guangdong Weiren Meditech Co., Ltd

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Properties

Show 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