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Taktvoll

by Beijing Taktvoll Technology Co., Ltd.

Ref ES-300D

Taktvoll (ES-300D) is an electrosurgical system (EU MDD Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Beijing Taktvoll Technology Co., Ltd., registered in EUDAMED on 10 Mar 2026 (Basic UDI-DI B-06972960400029), cleared under FDA 510(k) K240975 on 23 Dec 2024 and listed in FDA GUDID since 9 May 2026 (UDI-DI 06972960400029), active as of 25 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240975

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06972960400029 UDI-DI Date9 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-06972960400029 Basic UDI-DI 06972960400029UDI-DIDate10 Mar 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK240975 Date23 Dec 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06972960400029 registered 10 Mar 2026 Active
  • FDA 510(k) K240975 decided 23 Dec 2024 Active
  • FDA GUDID UDI-DI 06972960400029 listed 9 May 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K240975
  2. Registered EUDAMED B-06972960400029
  3. Listed FDA GUDID 06972960400029

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Electrosurgical system
Device name
High Frequency Surgical Generator
Model / reference
ES-300D
Primary DI / UDI-DI
06972960400029 EUDAMED
06972960404416 GUDID
Basic UDI-DI
B-06972960400029
510(k) Number
FDA product code
GEI
EMDN code
Z12010905 Radiosurgical units
GMDN term
Electrosurgical system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06972960400029
GUDID
06972960404416
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06972960400029; FDA GUDID lists 06972960404416), so their flags are not compared. 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.

Manufacturer details

EUDAMED SRN
CN-MF-000033674
Authorised representative
MedPath GmbH DE-AR-000000087

Similar devices in this category

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)