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US
Last updated May 23, 2026
What Baldus Sedation GmbH & Co. KG makes
Baldus Sedation GmbH & Co. KG manufactures single-use and reusable anaesthesia face masks and breathing circuits, as well as reusable ventilator breathing circuits. These products are designed for use in surgical and critical care settings to deliver controlled ventilation and oxygenation during anaesthesia and mechanical ventilation.
The company’s devices are classified under FDA regulations as Class I and Class II, with submissions recorded in the FDA’s 510(k) and UDI registries. The manufacturer is based in the US.
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 Baldus Sedation GmbH & Co. KG manufacture?
Baldus Sedation GmbH & Co. KG specializes in anaesthesia-related devices, including single-use and reusable anaesthesia face masks, as well as reusable and single-use anaesthesia breathing circuits. Additionally, they produce reusable ventilator breathing circuits. These products are primarily designed for use in surgical and critical care environments to support controlled ventilation and oxygen delivery during medical procedures.
Where is Baldus Sedation GmbH & Co. KG based?
The company is headquartered in the United States. This location is relevant for regulatory submissions and compliance with US-based medical device regulations.
Which regulatory registries list devices manufactured by Baldus Sedation GmbH & Co. KG?
Devices from Baldus Sedation GmbH & Co. KG are recorded in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) registry. These registries track submissions and device identification for compliance and transparency purposes.
How are the devices manufactured by Baldus Sedation GmbH & Co. KG classified under FDA regulations?
The company’s devices fall under FDA classification categories of Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and submission requirements for each device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 343104962
Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AirTechniques | NHP12SD | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NH-KIT | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NHA12SD | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NHA12HA | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NHAP101 | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NSP0030 | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NHK-3B3S | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NHP12BB | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NSC-VCB | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NHA12BD | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NSP0010 | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NHA12CV | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NHA12BB | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NSC-001 | FDA UDI | Class I | Active |
| AirTechiques | NHA12PG | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NHP12BD | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NHP12PG | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NHCO2-K | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NSP0020 | FDA UDI | Class I | Active |
| AirTechniques | NHP12HA | FDA UDI | Class I | Active |
| AirTechniques | NHP12CV | EUDAMEDFDA UDI | Class I | Active |
| AirTechniques | NHAA101 | EUDAMEDFDA UDI | Class I | Active |
| FlowStar Touch Digital Mixer Flowmeter | K222794 | FDA 510(k) | Class II | Active |
| FlowStar Analog Mixer Flowmeter | K230987 | FDA 510(k) | Class II | Active |
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