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Confocal Microprobe Imaging System

by Wuxi Hisky Medical Technologies Co., Ltd. EUDAMED

Active European Union

Ref /Model BrightP580

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697167994970S2 Basic UDI-DIDate26 May 2026RegisteredStatusActive

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  • Withdrawn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
BrightP580, /
Primary DI / UDI-DI
06971679949706
Direct Marketing DI
06971679949706
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000022547
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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