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Ampcare E Series Electrodes

by Ampcare, LLC 2 variants

Ref 50709LT

Ampcare E Series Electrodes (50709LT) is a device classified as Class I in the EU and Class II in the US made by Ampcare, LLC, registered in EUDAMED on 21 Apr 2026 (Basic UDI-DI 0867786000250709KM), cleared under FDA 510(k) K121483 on 15 Oct 2012 and listed in FDA GUDID since 15 Mar 2017 (UDI-DI 00867786000200), 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) K121483

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 Number0867786000250709KM Basic UDI-DI 00867786000200UDI-DIDate21 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00867786000200 UDI-DI Date15 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121483 Date15 Oct 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0867786000250709KM registered 21 Apr 2026 Active
  • FDA 510(k) K121483 decided 15 Oct 2012 Active
  • FDA GUDID UDI-DI 00867786000200 listed 15 Mar 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K121483
  2. Listed FDA GUDID 00867786000200
  3. Registered EUDAMED 0867786000250709KM

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  • Withdrawn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
Ampcare E Series Electrodes EUDAMED
E Series GUDID
Generic name
Transcutaneous electrical stimulation electrode, single-use
Model / Ref / Catalog
50709LT
Primary DI / UDI-DI
00867786000200
Basic UDI-DI
0867786000250709KM
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
Ireland
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-000038602
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under TENS SYSTEM ELECTRODES.

Other devices from Ampcare, LLC

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Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)