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Micromed SD LTM STIM

by Micromed, Inc.

Ref (01)08033928120828Model SD LTM STIM

Micromed SD LTM STIM is a device classified as Class IIb in the EU and Class II in the US made by Micromed, Inc., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-08033928120828), cleared under FDA 510(k) K180761 on 18 Jun 2018 and listed in FDA GUDID since 2 Jul 2018 (UDI-DI 08033928120828), active as of 7 Nov 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180761

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033928120828 Basic UDI-DI 08033928120828UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033928120828 UDI-DI Date2 Jul 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180761 Date18 Jun 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033928120828 registered 4 Nov 2026 Active
  • FDA 510(k) K180761 decided 18 Jun 2018 Active
  • FDA GUDID UDI-DI 08033928120828 listed 2 Jul 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180761
  2. Listed FDA GUDID 08033928120828
  3. Registered EUDAMED B-08033928120828

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Sd Ltm Stim EUDAMED
Micromed GUDID
Generic name
Somatosensory electrical stimulation system
Model / reference
SD LTM STIM, (01)08033928120828
Primary DI / UDI-DI
08033928120828
Basic UDI-DI
B-08033928120828
510(k) Number
FDA product code
GYC
EMDN code
Z12101106 Neurological stimulators
GMDN term
Somatosensory electrical stimulation system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.1310
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Somatosensory electrical stimulation system

Similar devices in this category

Other devices filed under NEUROLOGICAL STIMULATORS.

Other devices from Micromed, Inc.

See all devices from Micromed, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)