Skip to content

Megadyne

by Megadyne Medical Products, Inc. 116 variants

Ref MEGEN1Model Ethicon MEGADYNE Electrosurgical Generator(MEGEN1)

Megadyne (MEGEN1) is a device classified as Class IIb in the EU and Class II in the US made by Megadyne Medical Products, Inc., registered in EUDAMED on 9 Sep 2025 (Basic UDI-DI 0614559a00001BH), cleared under FDA 510(k) K213696 on 21 Jan 2022 (1 earlier submission) and listed in FDA GUDID since 14 Aug 2020 (UDI-DI 10614559105597), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213696↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0614559a00001BH Basic UDI-DI 10614559105597UDI-DIDate9 Sep 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK213696 Date21 Jan 2022IssuedStatusActive
United StatesGUDID listing GUDID Number10614559105597 UDI-DI Date14 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK193145 Date24 Mar 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0614559a00001BH registered 9 Sep 2025 Active
  • FDA 510(k) K213696 decided 21 Jan 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10614559105597 listed 14 Aug 2020 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K193145
  2. Listed FDA GUDID 10614559105597
  3. Cleared FDA 510(k) K213696
  4. Registered EUDAMED 0614559a00001BH

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Electrosurgical system generator
Model / Ref / Catalog
Ethicon MEGADYNE Electrosurgical Generator(MEGEN1), MEGEN1
Primary DI / UDI-DI
10614559105597
Basic UDI-DI
0614559a00001BH
Direct marketing DI
10614559105597
510(k) Number
FDA product code
GEI
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Electrosurgical system generator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Belgium
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.

Manufacturer details

EUDAMED SRN
US-MF-000017046
Authorised representative
Johnson & Johnson Medical GmbH DE-AR-000007712

Related devices

Category: Foot-switch, electrical

Similar devices in this category

Other devices filed under ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE.

Other devices from Megadyne Medical Products, Inc.

See all devices from Megadyne Medical Products, Inc. →

Properties

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