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J-Plasma APYX-JS3

by Apyx Medical Corporation

Ref APYX-JS3

J-Plasma APYX-JS3 is an electrosurgical system generator (EU MDD Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Apyx Medical Corporation, registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI B-00607151050108) and listed in FDA GUDID since 7 Jan 2020 (UDI-DI 00607151050108), active as of 24 Oct 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00607151050108 Basic UDI-DI 00607151050108UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00607151050108 UDI-DI Date7 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00607151050108 registered 24 Jun 2026 Active
  • FDA GUDID UDI-DI 00607151050108 listed 7 Jan 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00607151050108
  2. Registered EUDAMED B-00607151050108

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
J-Plasma® System Generator EUDAMED
J-Plasma GUDID
Generic name
Electrosurgical system generator
Model / Ref / Catalog
APYX-JS3
Primary DI / UDI-DI
00607151050108
Basic UDI-DI
B-00607151050108
FDA product code
GEI
EMDN code
Z12010905 Radiosurgical units
GMDN term
Electrosurgical system generator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
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 generator

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Other devices filed under RADIOSURGICAL UNITS.

Other devices from Apyx Medical Corporation

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Properties

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