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Big-Tip

by RF Medical Co., Ltd. 12 variants

Ref BTC 2035Model BT Series

Active European Union

CE MDR

Valid until

21 Sep 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880014291604BD Basic UDI-DI 08800142907708UDI-DIDate10 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • KR23/00000154 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    23 Apr 2026
    Expires
    21 Sep 2028
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Big-Tip, MYOBLATE™
Model / Reference
BT Series, BTC 2035
Primary DI / UDI-DI
08800142907708
Basic UDI-DI
880014291604BD
EMDN Code
K0201010301 Open electrosurgery electrodes, single-use
Device Class
Class IIb
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
KR-MF-000012647
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Rf Medical Co., Ltd

  • Big-Tip

    Class IIb

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    Class IIb

  • Jet-Tip®

    Class IIb

  • Thyblate™

    Class IIb

  • Timco

    Class IIb

  • VertiBlate™

    Class IIb

See all devices from Rf Medical 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