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50x100mm Electrode

by TensCare Ltd 2 variants

Ref E-TR50100Model Replacement Electrodes

50x100mm Electrode (E-TR50100) is a transcutaneous electrical stimulation electrode (EU MDR Class I; FDA Class II; FDA product code GXY, Electrode, Cutaneous) made by TensCare Ltd, registered in EUDAMED on 20 Feb 2025 (Basic UDI-DI 5033435E00069XL), cleared under FDA 510(k) K132588 on 22 Nov 2013 and listed in FDA GUDID since 6 Nov 2024 (UDI-DI 05033435139156), 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) K132588

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 Number5033435E00069XL Basic UDI-DI 05033435139156UDI-DIDate20 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05033435139156 UDI-DI Date6 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132588 Date22 Nov 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5033435E00069XL registered 20 Feb 2025 Active
  • FDA 510(k) K132588 decided 22 Nov 2013 Active
  • FDA GUDID UDI-DI 05033435139156 listed 6 Nov 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132588
  2. Listed FDA GUDID 05033435139156
  3. Registered EUDAMED 5033435E00069XL

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  • Withdrawn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
50x100mm Electrode EUDAMED
TensCare GUDID
Generic name
Transcutaneous electrical stimulation electrode, single-use
Device name
Replacement Electrodes
Model / Ref / Catalog
Replacement Electrodes, E-TR50100, Carbon Mesh Electrode pads 50X100 mm
Primary DI / UDI-DI
05033435139156
Basic UDI-DI
5033435E00069XL
510(k) Number
FDA product code
GXY
EMDN code
N010201 Tens system electrodes
GMDN term
Transcutaneous electrical stimulation electrode, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1320
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Replacement Electrodes
E-TR50100
GUDID
Carbon Mesh Electrode pads 50X100 mm
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
GB-MF-000004156
Authorised representative
Advena Limited MT-AR-000000234

Similar devices in this category

Other devices filed under TENS SYSTEM ELECTRODES.

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Properties

  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)