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Exactrace

by Conmed Corporation 2 variants

Part of a family of 67 devices: see the family page

Ref 1510-030

Exactrace (1510-030) is a device classified as Class I in the EU and Class II in the US made by Conmed Corporation, registered in EUDAMED on 6 Feb 2026 (Basic UDI-DI 084585408541DB), cleared under FDA 510(k) K963787 on 11 Mar 1997 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10653405003694), active as of 23 Oct 2026.

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

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K963787

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 Number084585408541DB Basic UDI-DI 10653405003694UDI-DIDate6 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10653405003694 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK963787 Date11 Mar 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084585408541DB registered 6 Feb 2026 Active
  • FDA 510(k) K963787 decided 11 Mar 1997 Active
  • FDA GUDID UDI-DI 10653405003694 listed 24 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K963787
  2. Listed FDA GUDID 10653405003694
  3. Registered EUDAMED 084585408541DB

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  • Withdrawn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

Generic name
Electrocardiographic electrode, single-use
Device name
Non-orthopedic, Non-active, Monitoring Electrode, Non-sterile
Model / Ref / Catalog
1510-030
Primary DI / UDI-DI
10653405003694
Basic UDI-DI
084585408541DB
Unit of use DI
00653405003697
510(k) Number
FDA product code
DRX
EMDN code
C020501 ECG electrodes
GMDN term
Electrocardiographic electrode, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2360
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.

Manufacturer details

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

Related devices

Category: Electrocardiographic electrode, single-use

Similar devices in this category

Other devices filed under ECG ELECTRODES.

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)