Question 1

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

Accepted Answer

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.

Question 2

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

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Avalon Cableless Toco+ MP Transducer	866075	EUDAMEDFDA UDI	Class IIb	Active
Neonatal Soft Single-Patient Nibp Cuffs	989803167551	EUDAMEDFDA UDI	Class I	Active
CBL 5+5 ECG Trunk cable AAMI, IEC 2.7m	989803125831	EUDAMEDFDA UDI	Class I	Active
Expression MR400 MRI Patient Monitor Sys	866185	EUDAMEDFDA UDI	Class IIb	Active
Gentle Care Cuff, Adult Xl, 1-Tube	M4576B	EUDAMEDFDA UDI	Class I	Active
IntelliVue G7m Anesthesia Gas Module	866173	EUDAMEDFDA UDI	Class IIb	Active
Thermal Paper For Pagewriter, 8.5"x11"	M2481A	EUDAMEDFDA UDI	Class I	Active
Infant Size 5 NBP Cuffs (10)	989803183211	EUDAMEDFDA UDI	Class I	Active
CBL 10 Lead ECG Trunk AAMI/IEC 2m	989803144791	EUDAMEDFDA UDI	Class I	Active
Gentle Care Cuff, Small Adult, 1-Tube	M4574B	EUDAMEDFDA UDI	Class I	Active
5 Leadset, Grabber, Chest, AAMI, ICU	989803125881	EUDAMED	Class I	Active
SPO2 Reus Adult Clip Sensor M1196T	989803205911	EUDAMEDFDA UDI	Class IIb	Active
Neonatal Nibp Air Hose 1.5m	M1596C	EUDAMED	Class I	Active
DigiTrak XT Patient Cable Medium	989803157491	EUDAMEDFDA UDI	Class I	Active
M1192A Reusable P-S-A Finger SpO2 Sensor	989803205871	EUDAMEDFDA UDI	Class IIb	Active
Neonatal Soft Single-Patient Cuff Size#3	M1870S	EUDAMEDFDA UDI	Class I	Active
PageWriter TC35 Cardiograph	860437	EUDAMEDFDA UDI	Class IIa	Active
5 Leads Set Disposable, Bedside Iec Rd	989803174211	EUDAMEDFDA UDI	Class I	Active
Neonatal Single-Patient Cuff Size #2	M1868B	EUDAMEDFDA UDI	Class I	Active
PW CBL Complete Lead Set IEC	989803151641	EUDAMED	Class I	Active
Airway Adapter Set - ET >4.0 mm	989803144521	EUDAMEDFDA UDI	Class IIa	Active
Neonatal ECG 3.0 Cable IEC	989803193771	EUDAMEDFDA UDI	Class I	Active
CBL 5 Leadset, Grabber, IEC, ICU	989803125851	EUDAMEDFDA UDI	Class I	Active
Neonatal Soft Single-Patient Cuff Size#1	M1866S	EUDAMEDFDA UDI	Class I	Active
Patient Information Center iX	866389	EUDAMEDFDA UDI	Class IIb	Active
IntelliVue FMS-4	865243	EUDAMEDFDA UDI	Class IIb	Active
Neonatal Size 2 NBP Cuffs (10)	989803183181	EUDAMEDFDA UDI	Class I	Active
Wireless ECG 3.0 Module (Networks 6-10)	989803194341	EUDAMEDFDA UDI	Class IIb	Active
Comfort Care Cuff, Adult Xl	M1574XL	EUDAMEDFDA UDI	Class I	Active
Efficia CM100	863300	EUDAMED	Class IIb	Active
Efficia 3-Lead Grabber, Aami	989803160651	EUDAMED	Class I	Active
EEG CBL 4CH Trunk Cable, 2.7m	989803180541	EUDAMEDFDA UDI	Class I	Active
Temperature Parameter Module	862291	EUDAMEDFDA UDI	Class IIb	Active
Efficia CM10	863301	EUDAMED	Class IIb	Active
Patient Information Center iX	866389	EUDAMED	Class IIb	Active
Avalon ECG/IUP Transducer	867247	EUDAMEDFDA UDI	Class IIb	Active
Defibrillator Chemical/Thermal Paper	989803138171	EUDAMED	Class I	Active
The Philips Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80 And Mp90 Intellivue Atient Monitors	K060541	FDA 510(k)	Class II	Active
The Philips Intellivue Mp60, Mp70, And Mp90 Patient Monitors, Release A.20	K031481	FDA 510(k)	Class II	Active
IntelliVue Multi-Measurement Module MMX	K181831	FDA 510(k)	Class II	Active
Modification To Philips Avalon Fetal Monitors Fm20 And Fm30	K062137	FDA 510(k)	Class II	Active
Intellivue Cl Spo2 Pod And Cl Nbp Pod, Philips Intellivue Patient Monitors Mp5, Mp5t, Mp5sc	K131913	FDA 510(k)	Class II	Active
Philips M3001a Multi Measurement Server	K090360	FDA 510(k)	Class II	Active
Philips Obtracevue Model Sw Rev. G.00	K100420	FDA 510(k)	Class II	Active
IntelliSpace Perinatal Rev.K.00	K173941	FDA 510(k)	Class II	Active
IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800	K161531	FDA 510(k)	Class II	Active
IntelliVue Capnography Extension, IntelliVue Microstream Extension	K172904	FDA 510(k)	Class II	Active
Philips Mp40, Mp50, Mp60, Mp70, Mp80 And Mp90 Intellivue Patient Monitors, Release D.00	K053522	FDA 510(k)	Class II	Active
Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors	K150975	FDA 510(k)	Class II	Active
Philips Disposable Spo2 Sensors Mii32a And M1133a.	K052377	FDA 510(k)	Class II	Active

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