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Clear-Jet Injection Catheter

by Finemedix Co., Ltd. 16 variants

Ref FM-EI0002(2300)(0.05T)CModel FM-EI0002(1800)(0.05T)C

Active European Union

CE MDR

Valid until

2 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0880932735EIGB Basic UDI-DI 08809327355716UDI-DIDate8 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2026-MDR/QS-030 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    2 Jun 2026
    Expires
    2 Jun 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Single-Use Endoscopic Injection Catheter
Model / Reference
FM-EI0002(1800)(0.05T)C, FM-EI0002(2300)(0.05T)C
Primary DI / UDI-DI
08809327355716
Basic UDI-DI
0880932735EIGB
EMDN Code
K0199 Endotherapy devices - other
Device Class
Class IIa
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
KR-MF-000021680
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Finemedix Co., Ltd.

See all devices from Finemedix Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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