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Sign in to claim this brandBaxter Medical Systems GmbH + Co. KG
Germany·DE-MF-000005071
Last updated September 19, 2026
What Baxter Medical Systems GmbH + Co. KG makes
Baxter Medical Systems GmbH + Co. KG manufactures electromechanical operating tables, including universal bases and tops, orthopaedic extensions, and vacuum-assisted patient positioning pads. Their portfolio also includes operating room lighting systems, surgical video cameras, and remote controls for theatre equipment.
The company’s devices are classified as Class I, Class II, or Class IIb under EU and FDA regulations, with listings in the EUDAMED and FDA’s UDI database. The manufacturer is based in Germany.
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 Baxter Medical Systems GmbH + Co. KG primarily manufacture?
Baxter Medical Systems GmbH + Co. KG specializes in electromechanical and non-powered devices for operating rooms. Their portfolio includes universal operating tables (with bases, tops, and orthopaedic extensions), patient positioning vacuum pads, operating room lighting systems, surgical video cameras, and remote controls for theatre equipment. These devices are designed to support surgical procedures and patient positioning in clinical settings.
Where is Baxter Medical Systems GmbH + Co. KG based, and what does this imply for its regulatory oversight?
The company is headquartered in Germany, which means its devices fall under EU regulatory frameworks. This includes classification under the EU Medical Device Regulation (MDR) or Medical Device Directive (MDD), where devices like operating tables and lighting systems are categorized as Class I, Class II, or Class IIb depending on their risk level and intended use. The German location also influences compliance requirements, such as mandatory EUDAMED listings for traceability.
Which regulatory registries list Baxter Medical Systems GmbH + Co. KG’s devices, and why is this important?
The company’s devices are listed in EUDAMED, the European Union’s medical device registry, and the FDA’s UDI (Unique Device Identification) database in the U.S. These listings are critical for transparency and traceability: EUDAMED ensures compliance with EU MDR/MDD requirements, while the FDA’s UDI system supports post-market surveillance and recall tracking in the U.S. Both registries help healthcare providers, regulators, and patients verify device authenticity and safety data.
How are Baxter Medical Systems GmbH + Co. KG’s devices classified under EU and FDA regulations?
The company’s devices are classified as Class I, Class II, or Class IIb depending on their risk level and intended use. For example, a basic operating room light system might fall under Class I (low risk), while an electromechanical operating table with advanced features could qualify as Class IIb (higher risk due to patient contact or critical functions). Classification determines regulatory requirements like clinical evaluations, conformity assessments, and post-market monitoring, ensuring devices meet safety and performance standards before market placement.
Why might a healthcare provider check the classification of Baxter Medical Systems GmbH + Co. KG’s devices?
Device classification impacts how strictly a product is regulated and monitored. For instance, Class IIb devices (like certain operating tables) require rigorous clinical evidence and third-party audits, while Class I devices (e.g., simple lighting systems) have fewer pre-market hurdles but still must comply with general safety principles. Providers may verify classification to confirm the device’s compliance level, intended use, and whether it aligns with their facility’s risk management protocols or procurement policies.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 7-9, Carl-Zeiss-Straße, Saalfeld, Germany
- Website
- www.baxter.com
- —
- —
- [email protected]
- Phone
- +49 3761 586 0
- PRRC Contact
- Bernd Schell
- EUDAMED SRN
- DE-MF-000005071
- FDA FEI Number
- —
- DUNS Number
- 330961223
Catalogue (1281)
Page 3 of 26| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| iLED | 4068110 | FDA UDI | Class II | Unknown |
| Hillrom™ | 1576815 | FDA UDI | Class I | Unknown |
| Trumpf Medical | 2071798 | FDA UDI | Class I | Unknown |
| Hillrom™ | 4544706 | FDA UDI | Class I | Unknown |
| Hillrom™ | 2080465 | FDA UDI | Class II | Unknown |
| Pads | 1790215 | FDA UDI | Class I | Unknown |
| Hillrom™ | 2077584 | FDA UDI | Class I | Unknown |
| Pads | 2080553 | FDA UDI | Class II | Unknown |
| Hillrom™ | 1385776 | FDA UDI | Class II | Unknown |
| Hillrom™ | 2080451 | FDA UDI | Class II | Unknown |
| Hillrom™ | 1790039 | FDA UDI | Class I | Unknown |
| Hillrom™ | 1756164 | FDA UDI | Class I | Unknown |
| Hillrom™ | 1789978 | FDA UDI | Class II | Unknown |
| Hillrom™ | 1790010 | FDA UDI | Class I | Unknown |
| Hillrom™ | 1474544 | FDA UDI | Class I | Unknown |
| Trumpf Medical | 1846384 | FDA UDI | Class I | Unknown |
| Hillrom™ | 1851979 | FDA UDI | Class I | Unknown |
| Ts 7500 | 2029419 | FDA UDI | Class I | Active |
| Hillrom™ | 1997423 | FDA UDI | Class I | Unknown |
| Trumpf Medical | 1768767 | FDA UDI | Class II | Unknown |
| Trumpf Medical | 2077580 | FDA UDI | Class II | Unknown |
| Back Sections | 1789976 | FDA UDI | Class II | Unknown |
| Hillrom™ | 1574732 | FDA UDI | Class I | Unknown |
| Pads | 1574544 | FDA UDI | Class I | Unknown |
| Hillrom™ | 1789958 | FDA UDI | Class I | Unknown |
| Hillrom™ | 1850971 | FDA UDI | Class I | Unknown |
| Hillrom™ | 1597669 | FDA UDI | Class II | Unknown |
| Ts 7500 | 1730720 | FDA UDI | Class II | Active |
| Trumpf Medical | 1955207 | FDA UDI | Class I | Unknown |
| Ts 7500 | 1846396 | FDA UDI | Class II | Active |
| Leg Sections | 2064465 | FDA UDI | Class II | Unknown |
| Hillrom™ | 2080443 | FDA UDI | Class II | Unknown |
| Hillrom | 1218858 | FDA UDI | Class I | Unknown |
| Pads | 1851926 | FDA UDI | Class I | Unknown |
| Hillrom™ | 4501001 | FDA UDI | Class II | Unknown |
| Trumpf Medical | 2064890 | FDA UDI | Class I | Unknown |
| Hillrom™ | 1346755 | FDA UDI | Class I | Unknown |
| Hillrom™ | 1570942 | FDA UDI | Class II | Unknown |
| Leg Sections | 2066986 | FDA UDI | Class II | Unknown |
| Pads | 4146024 | FDA UDI | Class I | Unknown |
| Pads | 2065417 | FDA UDI | Class II | Unknown |
| Ts 7500 | 1717023 | FDA UDI | Class I | Active |
| Trumpf Medical | 2064891 | FDA UDI | Class I | Unknown |
| Hillrom™ | 4549735 | FDA UDI | Class I | Unknown |
| Hillrom™ | 1258884 | FDA UDI | Class I | Unknown |
| Hillrom™ | 4544773 | FDA UDI | Class I | Unknown |
| Hillrom™ | 1850953 | FDA UDI | Class I | Unknown |
| Hillrom™ | 1610541 | FDA UDI | Class I | Unknown |
| Orthopedic Extension | 2069354 | FDA UDI | Class I | Unknown |
| Hillrom™ | 4544547 | FDA UDI | Class I | Unknown |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Baxter Medical Systems GmbH + Co. KG DE