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Skintact

by Leonhard Lang GmbH

Ref F-55, WR21A30, T-VO01, FS-50510(k) K140500

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

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140500↗

+4 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number9005531ECGElectrodesCM Basic UDI-DI Date20 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number19005531000725 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK140500 Date29 Jul 2014IssuedStatusActive

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

2 recalls · FDA

    • Terminated Z-0292-2016 FDA Class II initiated 2 Nov 2015

    There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected electrodes will transmit a poor signal or no signal at all before reaching the indicated expiration date.

    • Terminated Z-1350-2015 FDA Class II initiated 24 Feb 2015

    The electrodes may fail to transmit signals.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Electrocardiographic electrode, single-use
Device Name
ECG Electrode
Neutral Electrode
Model / Ref / Catalog
F-55, WR21A30, FS-50, T-VO01
Primary DI / UDI-DI
19005531000725, 19005531595979, 19005531580289, 19005531505480, 19005531000114, 19005531002699, 19005531001609, 19005531000060
Basic UDI-DI
9005531ECGElectrodesCM, 9005531NeutralElectrSC
Unit of Use DI
09005531000728, 09005531505483, 09005531000117, 09005531002692, 09005531580282, 09005531001602, 09005531000063
510(k) Number
FDA Product Code
DRX
EMDN Code
C020501, K02010202
GMDN Term
Electrocardiographic electrode, single-use
Device Class
Class I EUDAMED
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 870.2360
EU market of registration
Austria
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class I
Class IIb
510(k)
Class II
GUDID
Class II

Manufacturer details

EUDAMED SRN
AT-MF-000000426

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Properties

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

Other properties (20)

  • Sterile: 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