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XA25 J25BS

by VIOL Co., Ltd.

Ref J25BS

XA25 J25BS is an electrosurgical system (EU MDR Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by VIOL Co., Ltd., registered in EUDAMED on 13 Jan 2026 (Basic UDI-DI 880905233VIOLSBPEJTVH), cleared under FDA 510(k) K213612 on 23 Jun 2022 and listed in FDA GUDID since 29 Jun 2022 (UDI-DI 08809502330156), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213612

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880905233VIOLSBPEJTVH Basic UDI-DI 08809502330156UDI-DIDate13 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809502330156 UDI-DI Date29 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK213612 Date23 Jun 2022IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880905233VIOLSBPEJTVH registered 13 Jan 2026 Active
  • FDA 510(k) K213612 decided 23 Jun 2022 Active
  • FDA GUDID UDI-DI 08809502330156 listed 29 Jun 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213612
  2. Listed FDA GUDID 08809502330156
  3. Registered EUDAMED 880905233VIOLSBPEJTVH

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  • Withdrawn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
XA25
Generic name
Electrosurgical system
Device name
J Tip
Model / reference
J25BS
Primary DI / UDI-DI
08809502330156
Basic UDI-DI
880905233VIOLSBPEJTVH
510(k) Number
FDA product code
GEI
EMDN code
Z12010985 Electrosurgery instruments - consumables
GMDN term
Electrosurgical system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Greece
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: Electrosurgical system

Cleared under the same submission (K213612)

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS - CONSUMABLES.

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Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)