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Ship Unit M300+ MS33648

by Draeger Medical Systems, Inc.

Ref MS33648Model 307005VK13K010

Ship Unit M300+ MS33648 is a centralized patient monitor (EU MDR Class IIb; FDA Class II; FDA product code MHX, Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)) made by Draeger Medical Systems, Inc., registered in EUDAMED on 27 May 2026 (Basic UDI-DI 040486752307005VK13K0108A), cleared under FDA 510(k) K231477 on 17 Oct 2023 and listed in FDA GUDID since 19 Feb 2025 (UDI-DI 04049098095778), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231477

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/MDR EUDAMED Number040486752307005VK13K0108A Basic UDI-DI 04049098095778UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049098095778 UDI-DI Date19 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231477 Date17 Oct 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 040486752307005VK13K0108A registered 27 May 2026 Active
  • FDA 510(k) K231477 decided 17 Oct 2023 Active
  • FDA GUDID UDI-DI 04049098095778 listed 19 Feb 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231477
  2. Listed FDA GUDID 04049098095778
  3. Registered EUDAMED 040486752307005VK13K0108A

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  • Withdrawn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
Infinity® M300+ EUDAMED
Ship Unit M300+ GUDID
Generic name
Centralized patient monitor
Model / reference
MS33648, 307005VK13K010
Primary DI / UDI-DI
04049098095778
Basic UDI-DI
040486752307005VK13K0108A
Direct marketing DI
04049098095778
FDA product code
MHX
EMDN code
Z1203020202 Transportable/portable multi–parameter patient monitors
GMDN term
Centralized patient monitor
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.1025
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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: Centralized patient monitor

Cleared under the same submission (K231477)

Similar devices in this category

Other devices filed under TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS.

Other devices from Draeger Medical Systems, Inc.

See all devices from Draeger Medical Systems, Inc. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)