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Megadyne

by Megadyne Medical Products, Inc. United States EUDAMEDGUDID

Ref 0846

Product code GEIEMDN Z12010999

Regulatory status

as of 24 Oct 2026

Recall ongoing. 5 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-USMF000017046000126SA Basic UDI-DIDate20 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-USMF000017046000126SA UDI-DIDate11 Dec 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

5 recalls · 5 ongoing · FDA

    • Ongoing Z-0597-2024 FDA Class I initiated 8 Dec 2023

    Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

  • 4 recalls, same reason

    • Ongoing Z-2000-2023 FDA Class I initiated 1 Jun 2023
    • Ongoing Z-1999-2023 FDA Class I initiated 1 Jun 2023
    • Ongoing Z-2001-2023 FDA Class I initiated 1 Jun 2023
    • Ongoing Z-1998-2023 FDA Class I initiated 1 Jun 2023

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

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Megadyne EUDAMED
Mega Soft GUDID
Generic Name
Electrosurgical return electrode, reusable
Model / Ref / Catalog
0846
Primary DI / UDI-DI
D-USMF000017046000126SA EUDAMED
10614559104248 GUDID
Basic UDI-DI
B-USMF000017046000126SA
510(k) Number
FDA Product Code
GEI
EMDN Code
Z12010999 Electrosurgery instruments - other
GMDN Term
Electrosurgical return electrode, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-USMF000017046000126SA
GUDID
10614559104248
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

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

Other devices from Megadyne Medical Products, Inc.

See all devices from Megadyne Medical Products, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
  • Expiration Date
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED c03c489f-9073-43f8-a272-f7c871bf978a 61 fields · synced 22 Oct 2026
  • FDA UDI 837deb70-ddf0-48fc-b7a0-9f4e478e27ab 37 fields · synced 30 May 2026