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Expression MR400 MRI Patient Monitor Sys

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 866185Model MR400 MRI Patient Monitor

by Philips Medizin Systeme Böblingen GmbH

Identity

Trade Name
Expression MR400 MRI Patient Monitor Sys EUDAMED
MR Patient Care Expression Model MR400 MRI Patient Monitoring System FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
MR400 MRI Patient Monitor EUDAMED
Expression Patient Monitor (MR400): 15 inch Widescreen Touchscreen interface, MRI Rating 5,000 gauss 4W/kg SAR 3.0T, 8-Hour Smart Battery Technology, 3rd-Gen Wireless ECG with Advanced Filters, 3rd-Gen Wireless Pulse Oximetry (SpO2) with Perfusion Index, Single-Lumen Non-Invasive Blood Pressure (NIBP), CO2 monitoring with Respiration Rate, Wired and wireless gating with MRI systems, and Multi-priority alarm system with CDS. All parameters support Adult, Pediatric, Infant and Neonatal applications. One (1) day on-site Expression system training, One (1) year limited warranty and factory service for hardware. FDA UDI
Model / Reference
MR400 MRI Patient Monitor EUDAMED
866185 EUDAMED
Expression MR400 MRI Patient Monitor Sys FDA UDI
Description
Expression Patient Monitor (MR400): 15 inch Widescreen Touchscreen interface, MRI Rating 5,000 gauss 4W/kg SAR 3.0T, 8-Hour Smart Battery Technology, 3rd-Gen Wireless ECG with Advanced Filters, 3rd-Gen Wireless Pulse Oximetry (SpO2) with Perfusion Index, Single-Lumen Non-Invasive Blood Pressure (NIBP), CO2 monitoring with Respiration Rate, Wired and wireless gating with MRI systems, and Multi-priority alarm system with CDS. All parameters support Adult, Pediatric, Infant and Neonatal applications. One (1) day on-site Expression system training, One (1) year limited warranty and factory service for hardware. FDA UDI

Identifiers

Catalog Number
866185 FDA UDI
Primary DI / UDI-DI
00884838111363 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM1079MG EUDAMED
Direct Marketing DI
00884838111363 EUDAMED
FDA Product Code
MWI FDA UDI
EMDN Code
Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
GMDN Term
General-purpose multi-parameter bedside monitor FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Expression MR400 MRI Patient Monitor Sys by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Medizin Systeme Böblingen GmbH
EUDAMED SRN
DE-MF-000006026

Sources (2)

  • EUDAMED 940ac9b4-7ed9-476c-bbe5-9d79da3c3808 61 fields · synced Oct 6, 2026
  • FDA UDI a50f83e3-f766-4b52-96ca-7375478dc484 35 fields · synced May 30, 2026