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OsteoBlate™ BMDT 2120B

by RF Medical Co., Ltd.

Ref BMDT 2120BModel VCT Series

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

21 Sep 2028

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800142924491 UDI-DI Date13 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number880014291608BM Basic UDI-DI 08800142924491UDI-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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
OsteoBlate™
Generic Name
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
Device Name
V-TIP, MYOBLATE-V™, OsteoBlate™, VertiBlate™
Model / Reference
BMDT 2120B, VCT Series
Primary DI / UDI-DI
08800142924491
Basic UDI-DI
880014291608BM
510(k) Number
FDA Product Code
GEI, JOS
EMDN Code
K0201010301 Open electrosurgery electrodes, single-use
GMDN Term
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K232763)

Show all (12)

Other devices from RF Medical Co., Ltd.

  • VertiBlate™

    Class IIb

  • Big-Tip

    Class IIb

  • Myoblate™

    Class IIb

  • Jet-Tip®

    Class IIb

  • Hemotip

    Class IIb

  • Thyblate™

    Class IIb

See all devices from RF Medical Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No