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Dyna/Trace

by Conmed Corporation 7 variants

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

Ref 1550-005

Dyna/Trace (1550-005) 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) K991105 on 26 Nov 1999 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10653405003724), active as of 22 Oct 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None, self-declared

Class I: no certifier involved

510(k) K991105

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084585408541DB Basic UDI-DI 10653405003724UDI-DIDate6 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10653405003724 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK991105 Date26 Nov 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084585408541DB registered 6 Feb 2026 Active
  • FDA 510(k) K991105 decided 26 Nov 1999 Active
  • FDA GUDID UDI-DI 10653405003724 listed 24 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

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

Recalls

1 recall · FDA

    • Terminated Z-1184-03 FDA Unclassified (pre-2012) initiated 30 Jul 2003

    Separation of the sensing element from the body of the electrode.

Timeline

4 dated events

  1. Cleared FDA 510(k) K991105
  2. Recall initiated FDA recalls Z-1184-03
  3. Listed FDA GUDID 10653405003724
  4. 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  • Withdrawn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
1550-005
Primary DI / UDI-DI
10653405003724
Basic UDI-DI
084585408541DB
Unit of use DI
00653405003727
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
  • Manufacturing date
Other properties (21, all answered No)