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MR200 MRI Patient Monitoring System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 866120
Identity
- Trade Name
- MR200 MRI Patient Monitoring System EUDAMEDExpression MR200 MRI Patient Monitor System FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- MR200 MRI Patient Monitor EUDAMEDExpression MRI Patient Vital Signs Monitor (Model MR200). Wireless ECG, Wireless Pulse Oximetry (SpO2),Non-Invasive Blood Pressure (NIBP), Integrated End-Tidal CO2, Advanced ECG Filters, Trend Arrows, All parameters support Adult, Pediatric, Infant and Neonatal applications,8-Hour Smart Battery Technology, Gauss Detection Alarm. One (1) day on-site Expression system training. One (1) year limited warranty and factory service for hardware FDA UDI
- Model / Reference
- 866120 EUDAMEDMR200 MRI Patient Monitoring System FDA UDI
- Description
- Expression MRI Patient Vital Signs Monitor (Model MR200). Wireless ECG, Wireless Pulse Oximetry (SpO2),Non-Invasive Blood Pressure (NIBP), Integrated End-Tidal CO2, Advanced ECG Filters, Trend Arrows, All parameters support Adult, Pediatric, Infant and Neonatal applications,8-Hour Smart Battery Technology, Gauss Detection Alarm. One (1) day on-site Expression system training. One (1) year limited warranty and factory service for hardware FDA UDI
Identifiers
- Catalog Number
- 866120 FDA UDI
- Primary DI / UDI-DI
- 00884838033764 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838033764 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 EUDAMEDClass 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
MR Conditional FDA UDI
MR200 MRI Patient Monitoring System by Invivo, a division of Philips Medical Systems — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838033764 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Invivo, a division of Philips Medical Systems
- EUDAMED SRN
- US-MF-000002177
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (2)
- EUDAMED af163962-e308-4196-a853-972cd2ede901 61 fields · synced Oct 8, 2026
- FDA UDI 459a497f-3963-46f8-9978-d2a0fca1987f 36 fields · synced May 30, 2026