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Plaxpot Multi Plasma GPX-2000

by Gcs Co. Limited

Ref GPX-2000

Plaxpot Multi Plasma GPX-2000 is an electrosurgical handpiece (EU MDD Class IIb; FDA Class II; FDA product code QVJ, Low Power Electrosurgical Devices For Skin Lesion Destruction) made by Gcs Co. Limited, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 880958102GEA01CK), cleared under FDA 510(k) K220493 on 27 Oct 2023 and listed in FDA GUDID since 14 Nov 2024 (UDI-DI 08809581021792), active as of 7 Nov 2026.

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

CE MDR 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220493

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/MDD EUDAMED Number880958102GEA01CK Basic UDI-DI 08809581021792UDI-DIDate3 Nov 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number880958102GEA01CK Basic UDI-DI 08809581021792UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809581021792 UDI-DI Date14 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK220493 Date27 Oct 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880958102GEA01CK registered 3 Nov 2026 Active· +1 more in the status table
  • FDA 510(k) K220493 decided 27 Oct 2023 Active
  • FDA GUDID UDI-DI 08809581021792 listed 14 Nov 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K220493
  2. Listed FDA GUDID 08809581021792
  3. Registered EUDAMED 880958102GEA01CK

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Plaxpot Multi Plasma
Generic name
Electrosurgical handpiece, reusable
Device name
Electrosurgical device
Model / reference
GPX-2000
Primary DI / UDI-DI
08809581021792 EUDAMED
08809581025837 GUDID
Basic UDI-DI
880958102GEA01CK, B-08809581021792
510(k) Number
FDA product code
QVJ
EMDN code
L180301 Open electrosurgery handpieces, reusable
GMDN term
Electrosurgical handpiece, reusable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08809581021792
GUDID
08809581025837
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08809581021792; FDA GUDID lists 08809581025837), 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.

Related devices

Category: Electrosurgical handpiece, reusable

Similar devices in this category

Other devices filed under OPEN ELECTROSURGERY HANDPIECES, REUSABLE.

Other devices from Gcs Co. Limited

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)