Skip to content

Ophthalmic Reusable Pack

by Innolcon Medical Technology (Suzhou) Co., Ltd. EUDAMED

Active European Union

Ref FMSR100104Model FMSR100001, FMSR200001, FMSR300001, FMSR100101-FMSR100104, FMSR100201-FMSR100204, FMSR200101-FMSR200104, FMSR200201-FMSR200204, FMSR300101-FMSR300104, FMSR300201-FMSR300204

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697246494MD03100ORPM001YT Basic UDI-DIDate25 Oct 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  • Withdrawn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

Model / Reference
FMSR100001, FMSR200001, FMSR300001, FMSR100101-FMSR100104, FMSR100201-FMSR100204, FMSR200101-FMSR200104, FMSR200201-FMSR200204, FMSR300101-FMSR300104, FMSR300201-FMSR300204, FMSR100104
Primary DI / UDI-DI
06972464943756
Basic UDI-DI
697246494MD03100ORPM001YT
EMDN Code
Q020680 Phacoemulsification devices - accessories
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000012689
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Innolcon Medical Technology (Suzhou) Co., Ltd.

See all devices from Innolcon Medical Technology (Suzhou) Co., Ltd. →

Properties

  • Sterile
  • Reusable
  • CMR Substance

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No