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Mx40 - 2.4
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 865351Model MX40 Patient Wearable Monitor
Identity
- Trade Name
- MX40 - 2.4 EUDAMEDIntelliVue MX40 2.4GHz FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- MX40 Patient Wearable Monitor EUDAMEDIntelliVue MX40 Patient Worn Monitor operating on the IntelliVue 2.4 GHz Smart-hopping Network for communication to the Philips IntelliVue Information Center or Philips IntelliVue Information Center iX. FDA UDI
- Model / Reference
- MX40 Patient Wearable Monitor EUDAMED865351 EUDAMEDMX40 - 2.4 FDA UDI
- Description
- IntelliVue MX40 Patient Worn Monitor operating on the IntelliVue 2.4 GHz Smart-hopping Network for communication to the Philips IntelliVue Information Center or Philips IntelliVue Information Center iX. FDA UDI
Identifiers
- Catalog Number
- 865351 FDA UDI
- Primary DI / UDI-DI
- 00884838082243 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838082243 EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z12050803 ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
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 Unsafe FDA UDI
Mx40 - 2.4 by Philips Medical Systems — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00884838082243 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (2)
- EUDAMED 01ad0723-e99a-4d34-8f6f-044eb8019915 61 fields · synced Jul 8, 2026
- FDA UDI 23aaeeca-2c1e-471c-b6de-7501e364ef36 36 fields · synced May 30, 2026