Skip to content

myPatch®sl Adult Electrode

by dms-service, LLC

Part of a family of 6 devices: see the family page

Ref mpE3slModel 3000sl Accessory

myPatch®sl Adult Electrode (mpE3sl) is a device classified as Class I in the EU and Class II in the US made by dms-service, LLC, registered in EUDAMED on 6 Dec 2022 (Basic UDI-DI 0857522005mpE3slVB), cleared under FDA 510(k) K163535 on 22 Feb 2017 and listed in FDA GUDID since 6 May 2026 (UDI-DI 00857522005125), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163535

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00857522005125 UDI-DI Date6 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0857522005mpE3slVB Basic UDI-DI 00857522005125UDI-DIDate6 Dec 2022RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK163535 Date22 Feb 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0857522005mpE3slVB registered 6 Dec 2022 Active
  • FDA 510(k) K163535 decided 22 Feb 2017 Active
  • FDA GUDID UDI-DI 00857522005125 listed 6 May 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163535
  2. Registered EUDAMED 0857522005mpE3slVB
  3. Listed FDA GUDID 00857522005125

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  • Withdrawn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

Trade name
myPatch®sl Adult Electrode EUDAMED
myPatch® GUDID
Generic name
Electrocardiographic ambulatory recorder
Model / Ref / Catalog
3000sl Accessory EUDAMED
mpE3sl EUDAMED
sl GUDID
mp3sl GUDID
Description
myPatch®sl Ambulatory ECG Recorder (Holter)
Primary DI / UDI-DI
00857522005125
Basic UDI-DI
0857522005mpE3slVB
510(k) Number
FDA product code
DSH
EMDN code
Z12050480 Holter system instruments for cardiovascular parameters - hardware accessories
GMDN term
Electrocardiographic ambulatory recorder
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2800
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
3000sl Accessory
mpE3sl
GUDID
sl
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-000008977
Authorised representative
QNET B.V. NL-AR-000002695

Similar devices in this category

Other devices filed under HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES.

Other devices from dms-service, LLC

  • myPatch® 3 channel

    Class II

  • myPatch® s

    Class II

  • Mypatch

    Class II

  • myPatch-s

    Class II

See all devices from dms-service, LLC →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)