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Electrolase 7-101-12BX

by Conmed Corporation

Ref 7-101-12BX

Electrolase 7-101-12BX is a device classified as Class IIb in the EU and Class II in the US made by Conmed Corporation, registered in EUDAMED on 17 Jun 2026 (Basic UDI-DI B-10653405031659) and listed in FDA GUDID since 1 Dec 2023 (UDI-DI 10653405031659), 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-10653405031659 Basic UDI-DI 10653405031659UDI-DIDate17 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10653405031659 UDI-DI Date1 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10653405031659 registered 17 Jun 2026 Active
  • FDA GUDID UDI-DI 10653405031659 listed 1 Dec 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10653405031659
  2. Registered EUDAMED B-10653405031659

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  • Withdrawn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
Electrolase
Generic name
Open-surgery electrosurgical electrode, monopolar, single-use
Device name
Non-orthopedic, Active, Instrument, Electrosurgical, Electrode, Hyfrecator, Disposable
Model / Ref / Catalog
7-101-12BX
Primary DI / UDI-DI
10653405031659
Basic UDI-DI
B-10653405031659
FDA product code
GEI
EMDN code
K02030101 Radiofrequency surgery electrodes, single-use
GMDN term
Open-surgery electrosurgical electrode, monopolar, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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: Open-surgery electrosurgical electrode, monopolar, single-use

Similar devices in this category

Other devices filed under RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)