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TENS/EMS Electrode Procedure Pack DIS7000

by Laborie Medical Technologies Corp.

Ref DIS7000

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number62782500DIS7000D4 Basic UDI-DI 20627825008550UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20627825008550 UDI-DI Date19 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
TENS/EMS Electrode Procedure Pack
Generic Name
Electrode conductive skin pad, reusable
Device Name
TENS / EMS Electrode Procedure Pack
Model / Reference
DIS7000
Primary DI / UDI-DI
20627825008550
Basic UDI-DI
62782500DIS7000D4
EMDN Code
N010201 Tens system electrodes
GMDN Term
Electrode conductive skin pad, reusable
Device Class
Class I
Medical Purpose
Accessories to Laborie’s Urostym System are used to deliver stimulation during a treatment session.
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No