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Philips Medizin Systeme Böblingen GmbH

Germany·DE-MF-000006026

Last updated May 24, 2026

What Philips Medizin Systeme Böblingen GmbH makes

The company manufactures modular patient monitoring systems, including multifunction bedside monitors that track multiple vital signs, as well as reusable electrocardiographic lead sets and telemetric monitoring transmitters for cardiotocography and fetal Doppler applications. Additional products include respiration monitors, pulse oximeters, and clinical data interfacing software designed to integrate medical equipment with hospital information systems. Telemetry adapters with varying lead configurations and SpO₂ monitoring capabilities are also part of the portfolio, alongside thermal printer kits for ECG output.

These devices are regulated under EU Medical Device Regulations (Class I, II, IIa, and IIb) and are listed in the EUDAMED database, with corresponding FDA submissions via 510(k) and UDI registrations in the United States. The company’s products are also compliant with international standards such as IEC and AAMI for electrocardiographic leads and telemetry systems.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Philips Medizin Systeme Böblingen GmbH manufacture?

Philips Medizin Systeme Böblingen GmbH specializes in patient monitoring solutions, including multifunction bedside monitors that track multiple vital signs like ECG, respiration, and pulse oximetry. Their portfolio also includes reusable electrocardiographic lead sets, telemetric monitoring transmitters for fetal health (e.g., cardiotocography and Doppler systems), and clinical data interfacing software. These products are designed for seamless integration into hospital workflows, ensuring real-time monitoring and data connectivity.

Where is Philips Medizin Systeme Böblingen GmbH based, and how does this affect its regulatory compliance?

The company is based in Germany, which means its devices are regulated under the EU Medical Device Regulations (MDR). Since the company’s products fall into Class I, II, IIa, and IIb classifications, they must comply with EU requirements and are listed in the EUDAMED database. Additionally, their devices are also registered in the FDA’s 510(k) and UDI systems for the US market, reflecting their global regulatory scope.

Which regulatory registries list Philips Medizin Systeme Böblingen GmbH’s devices?

The company’s devices are officially listed in EUDAMED (the European Union’s medical device registry) due to their classification under EU MDR. For the United States, their products are documented via FDA 510(k) submissions and UDI (Unique Device Identifier) registrations, ensuring compliance with US regulatory requirements. These listings confirm their presence in both major medical device databases.

How are Philips Medizin Systeme Böblingen GmbH’s devices classified under medical device regulations?

The company’s devices span multiple risk-based classifications: Class I (low-risk items like reusable lead sets), Class II (moderate-risk products like bedside monitors and respiration monitors), and Class IIb (higher-risk systems such as telemetric monitoring transmitters and fetal Doppler probes). Classification depends on factors like intended use, risk to patients, and integration complexity, determining the regulatory scrutiny and compliance requirements each device must meet.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Germany
Address
2, Hewlett-Packard-Strasse, Böblingen, Germany
Website
n/a
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
n/a
PRRC Contact
Hauke Schik
EUDAMED SRN
DE-MF-000006026
FDA FEI Number
—
DUNS Number
314101143

Catalogue (441)

Page 4 of 9
DeviceModel / ReferenceRegistriesClassStatus
Ob Tracevue Obstetrical Information Management System With Release F.00 K081203
FDA 510(k)
Class IIActive
Philips Avalon Fetal Monitors Fm20, Fm30, Fm40, And Fm50 K092028
FDA 510(k)
Class IIActive
IntelliVue Patient monitors MX400, MX450, MX500, MX550 K251146
FDA 510(k)
Class IIActive
Intellivue Patient Monitors With Release C.02, Models Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80 And Mp90 K052801
FDA 510(k)
Class IIActive
The Philips Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80 And Mp90 Intellivue Patient Monitors K051106
FDA 510(k)
Class IIActive
Piconibp Oem Module K051366
FDA 510(k)
Class IIActive
Philips Mp5 Intellivue Patient Monitor K062392
FDA 510(k)
Class IIActive
Intellivue Patient Monitors, Models Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80 And Mp90 K063315
FDA 510(k)
Class IIActive
Intellivue Patient Monitor, Models Mp2, X2, Mp5, Mp5t, Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80, Mp90, & Mx800 K102562
FDA 510(k)
Class IIActive
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) K233440
FDA 510(k)
Class IIActive
Philips Anesthesia Gas Monitor, Model M1026b K040917
FDA 510(k)
Class IIActive
Philips Intellivue Mp5 Patient Monitor K083228
FDA 510(k)
Class IIActive
Philips Intellivue Patient Monitor, Models Mp20, Mp30, Mp40, Mp50, Mp60, Mp70 And Mp90 K050762
FDA 510(k)
Class IIActive
The Philips Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, And Mp90 Intellivue Patient Monitors K042845
FDA 510(k)
Class IIActive
Philips Holter Analysis System K241890
FDA 510(k)
Class IIActive
IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) K250453
FDA 510(k)
Class IIActive
Philips Mp5 And Mp5t Intellivue Patient Monitors And Trx4841a Intellivue Telemetry System Transceiver K081793
FDA 510(k)
Class IIActive
Telemetry Monitor 5500 Release 4.0 (867232) K242962
FDA 510(k)
Class IIActive
New: Intellivue Cl Respiration Pod New: Specialized Assessory: Mobile Cl Resp Attachment Modified: Intellivue Patient Mo K122223
FDA 510(k)
Class IIActive
Philips IntelliVue GuardianSoftware (Rev. E.0X) K212208
FDA 510(k)
Class IIActive
The Phillips, Model Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80, And Mp90 Intellivue Patient Monitors K060221
FDA 510(k)
Class IIActive
Modification To Agilent Component Monitoring System (cms), V24/V26 Patient Monitors, Blood Analysis Portal System Plug-I K013624
FDA 510(k)
Class IIActive
Philips Sp02 Disposable Sensor, Model M1131a K042306
FDA 510(k)
Class IIActive
Philips Intellivue Patient Monitor, Models Mp40 & Mp50 K040304
FDA 510(k)
Class IIActive
IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable K171801
FDA 510(k)
Class IIActive
The Philips Intellivue Mp40, Mp50, Mp60, Mp70, And Mp90 Patient Monitors, Release B.o. K032858
FDA 510(k)
Class IIActive
IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) K252726
FDA 510(k)
Class IIActive
IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension K181314
FDA 510(k)
Class IIActive
IntelliVue Measurement Rack 6000 (867317) K253654
FDA 510(k)
Class IIActive
Philips Avalon Fetal Monitor, Models Fm20 And Fm30 K052795
FDA 510(k)
Class IIActive
The Philips Mp20, Mp30, Mp40, Mp50, Mp60, Mp70 And Mp90 Intellivue Patient Monitors K050141
FDA 510(k)
Class IIActive
Philips Avalon Fetal / Maternal Monitors Fm20, Fm30, Fm40 And Fm50 K140535
FDA 510(k)
Class IIActive
Philips Mp20, Mp30, Mp40, Mp50. Mp60, Mp70 And Mp90 Intellivue Patient Monitors K041235
FDA 510(k)
Class IIActive
IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) K230604
FDA 510(k)
Class IIActive
Picosat Ii And M3002a Multimeasurement And M1020b Plug-In Modules Spo2 Pulse Oximetry Module K081937
FDA 510(k)
Class IIActive
Cardiac Workstation (5000); Cardiac Workstation (7000) K241556
FDA 510(k)
Class IIActive
Philips Model Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80 And Mp90 Intellivue Patient Monitors K061610
FDA 510(k)
Class IIActive
SPO2 Reus Adult Clip Sensor M1196A 989803205901
EUDAMEDFDA UDI
Class IIbActive
DigiTrak XT Patient Cable Long 989803157501
EUDAMED
Class IActive
Adult SpO2 Clip 989803166531
EUDAMEDFDA UDI
Class IActive
Invasive Blood Pressure Module 862277
EUDAMEDFDA UDI
Class IIbActive
Long Wide ECG 2.0 Cable IEC 989803185471
EUDAMED
Class IActive
5 Lead Set Snap IEC, ICU 989803145001
EUDAMED
Class IActive
Measurement Rack 6000 867317
EUDAMED
Class IActive
IntelliVue Capnography Extension 867040
EUDAMEDFDA UDI
Class IIbActive
IntelliVue Patient Monitor MX500 866064
EUDAMEDFDA UDI
Class IIbActive
862112 862112
EUDAMEDFDA UDI
Class IIbActive
CBL Unshielded 3 Lead Miniclip IEC 0.7m 989803144951
EUDAMEDFDA UDI
Class IActive
3 Leadset, Grabber, AAMI, ICU 989803145091
EUDAMED
Class IActive
Straight Sample Line H 989803144571
EUDAMEDFDA UDI
Class IIaActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Philips Medizin Systeme Boeblingen GmbH BOEBLINGEN Baden-Wurttemberg · DE FEI 3002807167