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
X2/MP2 External Power Supply	865122	FDA UDI	Class II	Unknown
IntelliVue MP2	865040	FDA UDI	Class II	Unknown
Cable, Electrode	989803145191	FDA UDI	Class II	Active
Microstream CO2 Extension	865377	FDA UDI	Class II	Active
IntelliVue CL NBP Pod	IntelliVue CL NBP Pod	FDA UDI	Class II	Active
PHILIPS Cordless Toco Transducer	862488	FDA UDI	Class II	Active
Hemodynamic Measurement Server Extension	Hemodynamic Measurement Server Extension	FDA UDI	Class II	Unknown
Philips IntelliVue ContactLess Biosensing	867111	FDA UDI	Class I	Active
IntelliVue Multi Measurement Server X2	865039	FDA UDI	Class II	Unknown
PHILIPS IntelliVue Spirometry Module	IntelliVue Spirometry Module	FDA UDI	Class II	Unknown
Neonatal Nibp Air Hose 3.0m	M1597C	EUDAMED	Class I	Active
Neonatal Single-Patient Cuff Size #4	M1872B	EUDAMEDFDA UDI	Class I	Active
Short Standard ECG 2.0 Cable AAMI	9224	EUDAMEDFDA UDI	Class I	Active
Neonatal Single-Patient Nibp Cuffs	989803167541	EUDAMEDFDA UDI	Class I	Active
Patient Information Center iX	866389	EUDAMEDFDA UDI	Class IIb	Active
Patient Information Center iX	866389	EUDAMEDFDA UDI	Class IIb	Active
Pediatric SpO2 Grips (20)	989803166561	EUDAMEDFDA UDI	Class I	Active
PW TC20 Long 10-Lead Patient Cable IEC	989803175911	EUDAMED	Class I	Active
Standard ECG 3.0 Cable AAMI	989803193731	EUDAMEDFDA UDI	Class I	Active
Easy Care Cuff, 1 Hose, Small Adult (1)	M4554B	EUDAMEDFDA UDI	Class I	Active
Gentle Care Cuff, Infant 1-Tube	M4572B	EUDAMEDFDA UDI	Class I	Active
Reusable Abdominal Belt- 60mm Wd, 15m Lg	M4603A	EUDAMEDFDA UDI	Class I	Active
Wireless ECG 3.0 Module (Networks 1-5)	989803192761	EUDAMEDFDA UDI	Class IIb	Active
Wide ECG 3.0 Cable AAMI	989803193721	EUDAMEDFDA UDI	Class I	Active
Comfort Care Cuff, Large Adult	M1575A	EUDAMEDFDA UDI	Class I	Active
Care Assist Android	989803221541	EUDAMEDFDA UDI	Class IIb	Active
Efficia 3/5 Ecg Trunk Cable, Aami/Iec	989803160641	EUDAMED	Class I	Active
IntelliVue XDS Software	867019	EUDAMEDFDA UDI	Class IIb	Active
Care Assist iOS	989803221531	EUDAMEDFDA UDI	Class IIb	Active
Chest Lead Set, AAMI/IEC	989803151671	EUDAMED	Class I	Active
Infant NBP Cuff	989803182611	EUDAMEDFDA UDI	Class I	Active
Wide ECG 3.0 Cable IEC	989803193751	EUDAMEDFDA UDI	Class I	Active
Neonatal ECG 3.0 Cable AAMI	989803193741	EUDAMEDFDA UDI	Class I	Active
SpO2 Grip Starter Kit (20 piece)	989803167111	EUDAMEDFDA UDI	Class I	Active
Limb Lead Set (Both AAMI and IEC)	989803151711	EUDAMED	Class I	Active
Easy Care Cuff, 1 Hose, Pediatric (1)	M4553B	EUDAMEDFDA UDI	Class I	Active
Large Adult-Long NBP Cuffs (10)	989803182571	EUDAMEDFDA UDI	Class I	Active
Neonatal Size 1 NBP Cuffs (10)	989803183171	EUDAMEDFDA UDI	Class I	Active
3 lead set, Disposable, Bedside, AAMI	989803173121	EUDAMEDFDA UDI	Class I	Active
Care Assist Android	989803221541	EUDAMED	Class IIb	Active
Avalon Cl Belt Clip	989803184851	EUDAMED	Class I	Active
SPO2 SPU Neo-Inf-Adlt Wrap Sensor M1133A	989803205851	EUDAMEDFDA UDI	Class IIb	Active
Paper-Met No Hdr	M1710A	EUDAMED	Class I	Active
Pediatric NBP Cuffs (10)	989803182521	EUDAMEDFDA UDI	Class I	Active
Comfort Care Cuff, Pediatric	M1572A	EUDAMEDFDA UDI	Class I	Active
Intellispace CC & Anesthesia	866148	EUDAMEDFDA UDI	Class IIb	Active
Disposable Abdominal Belts, 100/Cs	M2208A	EUDAMEDFDA UDI	Class I	Active
EEG CBL Lead Set Adult for 9 Elec.	989803180561	EUDAMEDFDA UDI	Class I	Active
Single-Patient use Infant Airway Adapter	989803142671	EUDAMEDFDA UDI	Class IIa	Active
Avalon Cableless Toco+ MP Transducer	866075	EUDAMEDFDA UDI	Class IIb	Active

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