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Omega-Solution MS25200

by Draeger Medical Systems, Inc.

Ref MS25200Model 002738

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Overview

Omega-Solution is a comprehensive 2-3 paragraph bedside monitor designed for continuous assessment of vital physiologic parameters in intensive or general healthcare settings. It features programmable alarms, portable radio transmitters, and receivers to allow monitoring during patient ambulation or transportation.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04049098002738 Basic UDI-DI 04049098002738UDI-DIDate18 Jun 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number04049098002738 UDI-DI Date2 Nov 2015ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Infinity Omega Monitor EUDAMED
Omega-Solution GUDID
Generic Name
General-purpose multi-parameter bedside monitor
Model / Reference
MS25200, 002738
Primary DI / UDI-DI
04049098002738
Basic UDI-DI
B-04049098002738
FDA Product Code
MHX, MSX
EMDN Code
Z1203020202 Transportable/portable multi–parameter patient monitors
GMDN Term
General-purpose multi-parameter bedside monitor
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.1025, 870.2300
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: General-purpose multi-parameter bedside monitor

Other devices from Draeger Medical Systems, Inc.

See all devices from Draeger Medical Systems, Inc. →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No