Is this your brand? Sign in to claim ownership.
Sign in to claim this brandPhilips 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
- —
- —
- [email protected]
- Phone
- n/a
- PRRC Contact
- Hauke Schik
- EUDAMED SRN
- DE-MF-000006026
- FDA FEI Number
- —
- DUNS Number
- 314101143
Catalogue (440)
Page 1 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Telemetry Adapter 6-Lead + Masimo SpO2 | 989803204291 | EUDAMED | Class I | Active |
| 12L Leadset, Grabber, IEC | 989803180131 | EUDAMED | Class I | Active |
| Telemetry Adapter 3L+SpO2 | 989803199101 | EUDAMED | Class I | Active |
| Telemetry Adapter SpO2-only | 989803199081 | EUDAMED | Class I | Active |
| Telemetry Adapter Masimo SpO2-only | 989803202391 | EUDAMED | Class I | Active |
| ECG 5 lead Grabber, AAMI, Tele | 989803171831 | EUDAMED | Class I | Active |
| Thermal Printer Kit, USB | 989803205011 | EUDAMED | Class I | Active |
| ECG 5 lead Snaps, AAMI + SpO2, Tele | 989803171841 | EUDAMED | Class I | Active |
| ECG 6 lead Grabber, IEC, Tele | 989803171961 | EUDAMED | Class I | Active |
| Telemetry Adapter 5-Lead + Masimo SpO2 | 989803202381 | EUDAMED | Class I | Active |
| ECG 5 lead Grabber, AAMI, SPU, Tele | 989803172031 | EUDAMED | Class I | Active |
| 12L Leadset, Snaps, IEC | 989803180151 | EUDAMED | Class I | Active |
| Telemetry Adapter 5L+SpO2 | 989803199091 | EUDAMED | Class I | Active |
| Telemetry Adapter 6L+SpO2 | 989803199071 | EUDAMED | Class I | Active |
| ECG 5L Grabber, IEC, Masimo SpO2 , Tele | 989803202421 | EUDAMED | Class I | Active |
| ECG 3 lead Grabber, IEC + SpO2, Tele | 989803171911 | EUDAMED | Class I | Active |
| ECG 5 lead Grabber, AAMI + SpO2, Tele | 989803171851 | EUDAMED | Class I | Active |
| Reusable Adult SpO2 Clip Sensor (3m) (M1196A) | K252821 | FDA 510(k) | Class II | Active |
| IntelliVue CL Respiration Pod | IntelliVue CL Respiration Pod | FDA UDI | Class II | Active |
| Microstream CO2 Extension | 862393 | FDA UDI | Class II | Active |
| MR Patient Care Portal Remote Display # 5000 | MR Patient Care Portal 5000 | FDA UDI | Class II | Active |
| PHILIPS IntelliVue TcG10 | IntelliVue TcG10 | FDA UDI | Class II | Unknown |
| Avalon US Transducer | Avalon US Transducer | FDA UDI | Class II | Active |
| IntelliVue Patient Monitor XG50 | 866063 | FDA UDI | Class II | Active |
| Capnography extension | 862187 | FDA UDI | Class II | Active |
| PHILIPS Transcutaneous pO2/pCO2 Parameter Module | 862283 | FDA UDI | Class II | Active |
| Avalon TOCO+ Transducer | Avalon TOCO+ Transducer | FDA UDI | Class II | Active |
| PHILIPS IntelliVue Tympanic Temperature Module | Tympanic Temperature Module | FDA UDI | Class II | Unknown |
| PHILIPS BIS Module | 862293 | FDA UDI | Class II | Active |
| Cable, Electrode | 989803144881 | FDA UDI | Class II | Active |
| PHILIPS EEG Parameter Module | 862290 | FDA UDI | Class II | Active |
| Anesthesia Gas Watertrap | Watertrap | FDA UDI | Class II | Unknown |
| IntelliVue GuardianSoftware | IntelliVue GuardianSoftware | FDA UDI | Class II | Active |
| IntelliVue CL SpO2 Pod | IntelliVue CL SpO2 Pod | FDA UDI | Class II | Active |
| IntelliVue XDS Software | IntelliVue XDS Software | FDA UDI | Class II | Active |
| Cable, Electrode | 989803144891 | FDA UDI | Class II | Active |
| Avalon TOCO MP Transducer | Avalon TOCO MP Transducer | FDA UDI | Class II | Active |
| IntelliVue GuardianSoftware | IntelliVue GuardianSoftware | FDA UDI | Class II | Active |
| EarlyVue VS30 | EarlyVue VS30 Vitals monitor | FDA UDI | Class II | Active |
| PHILIPS External Device Interface Module | 862292 | FDA UDI | Class II | Active |
| PHILIPS IntelliVue MP2 Military | 867059 | FDA UDI | Class II | Unknown |
| PHILIPS Cordless Ultrasound Transducer | 862489 | FDA UDI | Class II | Active |
| IntelliVue Multi Measurement Server SLCP | IntelliVue Multi Measurement Server SLCP | FDA UDI | Class II | Active |
| PHILIPS IntelliVue MX600 patient monitor | 865242 | FDA UDI | Class II | Active |
| Avalon Patient Module | Avalon Patient Module | FDA UDI | Class II | Active |
| IntelliVue Multi Measurement Server | IntelliVue Multi Measurement Server | FDA UDI | Class II | Active |
| Avalon Ultrasound Transducer USA | Avalon US Transducer USA | FDA UDI | Class II | Active |
| PHILIPS Cordless ECG Transducer | 862490 | FDA UDI | Class II | Active |
| X2/MP2 External Power Supply | 865122 | FDA UDI | Class II | Unknown |
| IntelliVue MP2 | 865040 | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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