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FineTome

by Finemedix Co., Ltd. 6 variants

Part of a family of 6 devices: see the family page

Ref FT-5300Model FineTome

FineTome (FT-5300) is a Class IIb device made by Finemedix Co., Ltd., registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI B-08809327353545), active as of 23 Oct 2026.

Active European Union

CE MDR CE MDD

Valid until

No date given

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

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-08809327353545 Basic UDI-DI 08809327353545UDI-DIDate16 Sep 2026RegisteredStatusActive
European UnionCE/MDD NumberB-08809327353545 Basic UDI-DI 08809327353545UDI-DIDate16 Sep 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Model / reference
FineTome, FT-5300
Primary DI / UDI-DI
08809327353545
Basic UDI-DI
B-08809327353545, 0880932735FTH4
EMDN code
K0201010301 Open electrosurgery electrodes, single-use
Device class
Class IIb
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Spain

Manufacturer details

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

Similar devices in this category

Other devices filed under OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE.

Other devices from Finemedix Co., Ltd.

See all devices from Finemedix Co., Ltd. →

Properties

  • Supplied sterile
Other properties (13, all answered No)