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Mega 2000 0825

by Megadyne Medical Products, Inc.

Ref 0825

Mega 2000 0825 is an electrosurgical system generator (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 0614559a00006BT), cleared under FDA 510(k) K982826 on 6 Nov 1998 and listed in FDA GUDID since 5 Sep 2018 (UDI-DI 10614559100943), active as of 23 Oct 2026. One FDA recall is linked to it.

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K982826

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 Number0614559a00006BT Basic UDI-DI 10614559100943UDI-DIDate24 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10614559100943 UDI-DI Date5 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK982826 Date6 Nov 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0614559a00006BT registered 24 Oct 2025 Active
  • FDA 510(k) K982826 decided 6 Nov 1998 Active
  • FDA GUDID UDI-DI 10614559100943 listed 5 Sep 2018 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1994-2023 FDA Class I initiated 1 Jun 2023

    Firm has received reports of patient burns in surgical procedures where device was used.

Timeline

4 dated events

  1. Cleared FDA 510(k) K982826
  2. Listed FDA GUDID 10614559100943
  3. Recall initiated FDA recalls Z-1994-2023
  4. Registered EUDAMED 0614559a00006BT

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  • Withdrawn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
Megadyne EUDAMED
Mega 2000 GUDID
Generic name
Electrosurgical system generator
Device name
MEGADYNE MEGA Sheath
Model / Ref / Catalog
0825
Primary DI / UDI-DI
10614559100943
Basic UDI-DI
0614559a00006BT
Direct marketing DI
10614559100943
510(k) Number
FDA product code
GEI
EMDN code
Z12010985 Electrosurgery instruments - consumables
GMDN term
Electrosurgical system generator
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 system generator

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

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