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ClearCut Knife

by Finemedix Co., Ltd. 30 variants

Ref FM-EK0004(1820)AModel ClearCut Knife

Active European Union

CE MDR CE MDD

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 NumberB-08809327351145 Basic UDI-DI 08809327351145UDI-DIDate16 Sep 2026RegisteredStatusActive
European UnionCE/MDD NumberB-08809327351145 Basic UDI-DI 08809327351145UDI-DIDate16 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2026-MDR/QS-028 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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Device Name
Single-Use Electrosurgical Knife
Model / Reference
ClearCut Knife, FM-EK0004(1820)A
Primary DI / UDI-DI
08809327351145
Basic UDI-DI
B-08809327351145, 0880932735EKGF
EMDN Code
K0201010301 Open electrosurgery electrodes, single-use
Device Class
Class IIb
EU market of registration
Türkiye

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