Skip to content

Mega Soft PKIT001

by Megadyne Medical Products, Inc.

Ref PKIT001

Mega Soft PKIT001 is an electrosurgical return electrode (EU MDR Class I; FDA Class II; FDA product code GEI, Electrosurgical, cutting & coagulation & accessories) made by Megadyne Medical Products, Inc., registered in EUDAMED on 24 Oct 2025 (Basic UDI-DI 0614559a00011BL) and listed in FDA GUDID since 5 Sep 2018 (UDI-DI 10614559101803), active as of 25 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0614559a00011BL Basic UDI-DI 10614559101803UDI-DIDate24 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10614559101803 UDI-DI Date5 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0614559a00011BL registered 24 Oct 2025 Active
  • FDA GUDID UDI-DI 10614559101803 listed 5 Sep 2018 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 10614559101803
  2. Registered EUDAMED 0614559a00011BL

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Megadyne EUDAMED
Mega Soft GUDID
Generic name
Electrosurgical return electrode, reusable
Device name
MEGADYNE MEGA SOFT Repair Kit
Model / Ref / Catalog
PKIT001
Primary DI / UDI-DI
10614559101803
Basic UDI-DI
0614559a00011BL
FDA product code
GEI
EMDN code
Z12010985 Electrosurgery instruments - consumables
GMDN term
Electrosurgical return electrode, reusable
Device class
Class I 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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 return electrode, reusable

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS - CONSUMABLES.

Other devices from Megadyne Medical Products, Inc.

See all devices from Megadyne Medical Products, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)