Skip to content

Megadyne 0035H

by Megadyne Medical Products, Inc.

Ref 0035H

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-USMF000017046000032RY Basic UDI-DI D-USMF000017046000032RYUDI-DIDate20 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-USMF000017046000032RY UDI-DI Date8 Dec 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Megadyne
Generic Name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Model / Ref / Catalog
0035H
Primary DI / UDI-DI
D-USMF000017046000032RY EUDAMED
10614559100493 GUDID
Basic UDI-DI
B-USMF000017046000032RY
FDA Product Code
GEI
EMDN Code
K0201010501 Open electrosurgery handpieces, single-use
GMDN Term
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-USMF000017046000032RY
GUDID
10614559100493
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Megadyne Medical Products, Inc.

See all devices from Megadyne Medical Products, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Serial Number: No
  • Manufacturing Date: No