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by Conmed Corporation 5 variants

Ref 2-1003

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

12 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-30653405059268 Basic UDI-DI 30653405059268UDI-DIDate13 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30653405059268 UDI-DI Date24 Sep 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.

Recalls

12 recalls · FDA

  • 10 recalls, same reason

    • Terminated Z-0091-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0085-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0086-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0088-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0083-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0092-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0089-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0090-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0084-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006
    • Terminated Z-0087-2007 FDA Unclassified (pre-2012) initiated 12 Oct 2006

    The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.

  • 2 recalls, same reason

    • Terminated Z-1434-06 FDA Unclassified (pre-2012) initiated 27 Mar 2006
    • Terminated Z-1433-06 FDA Unclassified (pre-2012) initiated 27 Mar 2006

    Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures.

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  • Withdrawn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

Generic Name
Endoscopic electrosurgical electrode, monopolar, reusable
Device Name
Non-orthopedic, Active, Instrument, Electrosurgical, Handle and Interchangeable Instrument
Model / Ref / Catalog
2-1003
Primary DI / UDI-DI
30653405059268
Basic UDI-DI
B-30653405059268
510(k) Number
FDA Product Code
GEI
EMDN Code
L180602 Endoscopic electrosurgery electrodes, reusable
GMDN Term
Endoscopic electrosurgical electrode, monopolar, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 33 Centimeter
Outer Diameter — 5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

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

Other properties (20)

  • 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
  • Serial Number: No
  • Manufacturing Date: No