Skip to content

Micromed SD LTM 64 PLUS

by Micromed, Inc.

Ref (01)08033928120897Model SD LTM 64 PLUS

Micromed SD LTM 64 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 15 May 2026 (Basic UDI-DI B-08033928120897), cleared under FDA 510(k) K071782 on 10 Jan 2008 and listed in FDA GUDID since 21 May 2018 (UDI-DI 08033928120897), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K071782

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033928120897 Basic UDI-DI 08033928120897UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033928120897 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-08033928120897 registered 15 May 2026 Active
  • FDA 510(k) K071782 decided 10 Jan 2008 Active
  • FDA GUDID UDI-DI 08033928120897 listed 21 May 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K071782
  2. Listed FDA GUDID 08033928120897
  3. Registered EUDAMED B-08033928120897

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  • Withdrawn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 64 Plus EUDAMED
Micromed GUDID
Generic name
Patient monitoring system module, electroencephalographic
Model / reference
SD LTM 64 PLUS, (01)08033928120897
Primary DI / UDI-DI
08033928120897
Basic UDI-DI
B-08033928120897
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)