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Thyblate-V2™ RFTVS2 07XXV

by RF Medical Co., Ltd.

Part of a family of 10 devices: see the family page

Ref RFTVS2 07XXVModel RFTV Series

Thyblate-V2™ RFTVS2 07XXV is a device classified as Class IIb in the EU and Class II in the US made by RF Medical Co., Ltd., registered in EUDAMED on 9 Jul 2026 (Basic UDI-DI 880014291925C4), cleared under FDA 510(k) K232763 on 4 Oct 2023 and listed in FDA GUDID since 5 Feb 2025 (UDI-DI 08800142925115), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

21 Sep 2028

CE MDR certificate

FDA recalls

None found

in data synced 7 Nov 2026

Documents

1 certificate

Certifier SGS Belgium NV

510(k) K232763

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880014291925C4 Basic UDI-DI 08800142925115UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800142925115 UDI-DI Date5 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK232763 Date4 Oct 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880014291925C4 registered 9 Jul 2026 Active
  • FDA 510(k) K232763 decided 4 Oct 2023 Active
  • FDA GUDID UDI-DI 08800142925115 listed 5 Feb 2025 Listed

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K232763
  2. Listed FDA GUDID 08800142925115
  3. Registered EUDAMED 880014291925C4

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Thyblate-V2™
Generic name
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
Device name
Thyblate-V™
Model / reference
RFTVS2 07XXV, RFTV Series
Primary DI / UDI-DI
08800142925115
Basic UDI-DI
880014291925C4
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 registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

Cleared under the same submission (K232763)

and 8 more cleared under K232763

Similar devices in this category

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

Other devices from RF Medical Co., Ltd.

  • VertiBlate™

    Class IIb

  • Big-Tip

    Class IIb

  • Myoblate™

    Class IIb

  • Jet-Tip®

    Class IIb

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

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)