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Ophthalmic Reusable Pack

by Innolcon Medical Technology (Suzhou) Co., Ltd. 39 variants

Ref FMSR300102Model FMSR100001, FMSR200001, FMSR300001, FMSR100101-FMSR100104, FMSR100201-FMSR100204, FMSR200101-FMSR200104, FMSR200201-FMSR200204, FMSR300101-FMSR300104, FMSR300201-FMSR300204

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697246494MD03100ORPM001YT Basic UDI-DI 06972464944395UDI-DIDate25 Oct 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
FMSR100001, FMSR200001, FMSR300001, FMSR100101-FMSR100104, FMSR100201-FMSR100204, FMSR200101-FMSR200104, FMSR200201-FMSR200204, FMSR300101-FMSR300104, FMSR300201-FMSR300204, FMSR300102
Primary DI / UDI-DI
06972464944395
Basic UDI-DI
697246494MD03100ORPM001YT
EMDN Code
Q020680 Phacoemulsification devices - accessories
Device Class
Class IIa
EU 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