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Surefit

by Conmed Corporation 3 variants

Ref 410-2100

Surefit (410-2100) is a device classified as Class IIb in the EU and Class II in the US made by Conmed Corporation, registered in EUDAMED on 11 Apr 2026 (Basic UDI-DI B-30653405033848), cleared under FDA 510(k) K120322 on 12 Jun 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 30653405033848), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K120322↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-30653405033848 Basic UDI-DI 30653405033848UDI-DIDate11 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30653405033848 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK120322 Date12 Jun 2012IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30653405033848 registered 11 Apr 2026 Active
  • FDA 510(k) K120322 decided 12 Jun 2012 Active
  • FDA GUDID UDI-DI 30653405033848 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K120322
  2. Listed FDA GUDID 30653405033848
  3. Registered EUDAMED B-30653405033848

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
Electrosurgical return electrode, single-use
Device name
Non-orthopedic, Active, Dispersive Electrode, Gel
Model / Ref / Catalog
410-2100
Primary DI / UDI-DI
30653405033848
Basic UDI-DI
B-30653405033848
FDA product code
GEI
EMDN code
K02010202 Electrosurgery dual patient pads (neutral electrodes), single-use
GMDN term
Electrosurgical return electrode, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

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

Related devices

Category: Electrosurgical return electrode, single-use

Similar devices in this category

Other devices filed under ELECTROSURGERY DUAL PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)