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Fiber Optic Microprobe

by Wuxi Hisky Medical Technologies Co., Ltd. FDA registration: China EUDAMED

Ref /Model L30 EMDN Z12020401

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697167994888SG 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  • Withdrawn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 · synced 22 Oct 2026

Model / Reference
L30, /
Primary DI / UDI-DI
06971679948884
Basic UDI-DI
697167994888SG
EMDN Code
Z12020401 Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

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

Other devices from Wuxi Hisky Medical Technologies Co., Ltd.

See all devices from Wuxi Hisky Medical Technologies Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reprocessed
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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 2753464c-7d4a-48f8-86ef-c425ef837fb7 61 fields · synced 22 Oct 2026