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Micromed SD LTM 32 PLUS

by Micromed, Inc.

Ref (01)08033928120903Model SD LTM 32 PLUS

Micromed SD LTM 32 PLUS 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-08033928120903), cleared under FDA 510(k) K071782 on 10 Jan 2008 and listed in FDA GUDID since 21 May 2018 (UDI-DI 08033928120903), 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) K071782

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-08033928120903 Basic UDI-DI 08033928120903UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033928120903 UDI-DI Date21 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK071782 Date10 Jan 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033928120903 registered 4 Nov 2026 Active
  • FDA 510(k) K071782 decided 10 Jan 2008 Active
  • FDA GUDID UDI-DI 08033928120903 listed 21 May 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K071782
  2. Listed FDA GUDID 08033928120903
  3. Registered EUDAMED B-08033928120903

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  • Withdrawn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 32 Plus EUDAMED
Micromed GUDID
Generic name
Patient monitoring system module, electroencephalographic
Model / reference
SD LTM 32 PLUS, (01)08033928120903
Primary DI / UDI-DI
08033928120903
Basic UDI-DI
B-08033928120903
510(k) Number
FDA product code
OLV, GWQ
EMDN code
Z1203020280 Multi-parameter monitors - hardware accessories
GMDN term
Patient monitoring system module, electroencephalographic
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.1400
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: Patient monitoring system module, electroencephalographic

Cleared under the same submission (K071782)

and 2 more cleared under K071782

Similar devices in this category

Other devices filed under MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES.

Other devices from Micromed, Inc.

See all devices from Micromed, Inc. →

Properties

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