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Sign in to claim this brandHoneywell Healthcare Solutions GmbH
Germany·DE-MF-000004924
Last updated May 24, 2026
What Honeywell Healthcare Solutions GmbH makes
Honeywell Healthcare Solutions GmbH manufactures respiratory oxygen sensors, anaesthesia gas flowmeters, reusable breathing circuit gas-flow sensors, and pulse oximeters. Their product line also includes line-powered respiratory oxygen monitors and related oxygen sensors for medical monitoring applications.
The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, and Class IIb, with listings in the EU’s eudamed database and the FDA’s UDI system. 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 Honeywell Healthcare Solutions GmbH primarily manufacture?
Honeywell Healthcare Solutions GmbH specializes in respiratory and monitoring devices. Their product range includes respiratory oxygen sensors, anaesthesia gas flowmeters, reusable breathing circuit gas-flow sensors, pulse oximeters, and line-powered respiratory oxygen monitors. These devices are designed for critical monitoring applications in medical settings, ensuring accurate measurement and delivery of gases during patient care.
Where is Honeywell Healthcare Solutions GmbH based, and how does this affect its regulatory compliance?
The company is based in Germany, which means its devices must comply with the European Union’s Medical Device Regulations (MDR). Since the company’s products are listed in the EU’s eudamed database and the FDA’s UDI system, they are subject to both European and U.S. regulatory requirements. The German location also influences classification under EU MDR, where their devices fall into Class I, Class II, and Class IIb categories.
Which regulatory registries list Honeywell Healthcare Solutions GmbH’s medical devices?
Honeywell Healthcare Solutions GmbH’s devices are officially listed in two key regulatory databases: the EU’s eudamed system, which tracks medical devices authorized under EU Medical Device Regulations, and the FDA’s UDI (Unique Device Identification) system, which ensures traceability of devices marketed in the United States. These listings help healthcare providers and regulators verify compliance and device details.
How are Honeywell Healthcare Solutions GmbH’s devices classified under EU regulations?
Under the EU Medical Device Regulations (MDR), Honeywell Healthcare Solutions GmbH’s devices are classified as Class I, Class II, or Class IIb, depending on their risk level and intended use. Class I devices pose the lowest risk (e.g., simple monitoring sensors), while Class IIb devices carry higher risks (e.g., critical flowmeters in anaesthesia). The classification determines the regulatory scrutiny and conformity assessment requirements each device must meet before authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 18, Alter Holzhafen, Wismar, Germany
- Website
- www.envitec.com/kontakt.html
- —
- —
- [email protected]
- Phone
- +493841360324
- PRRC Contact
- Marko Sprössel
- EUDAMED SRN
- DE-MF-000004924
- FDA FEI Number
- —
- DUNS Number
- 330943838
Catalogue (184)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SoftTip® medium | RM-3412-10 Ohmeda | FDA UDI | Class II | Unknown |
| Disposable Sensor | DP-2221-2 BCI | FDA UDI | Class II | Unknown |
| Oxygen Sensor | OOMLF111 | FDA UDI | Class II | Active |
| Oxygen Sensor | OOM105 | FDA UDI | Class II | Active |
| Oxygen Sensor | OOM202 | FDA UDI | Class II | Active |
| FingerClip | F-2414-15 HP/Philips | FDA UDI | Class II | Unknown |
| FingerClip | F-3212-9 MySign | FDA UDI | Class II | Unknown |
| Flow sensor | SpiroQuant H | FDA UDI | Class I | Active |
| Oxygen Sensor | OOMLF110 | FDA UDI | Class II | Active |
| Oxygen Sensor | OOM103 | FDA UDI | Class II | Active |
| Disposable Sensor | DP-2211-2 OEM Nellcor | FDA UDI | Class II | Unknown |
| FingerClip | F-3227 WEI Weinmann | FDA UDI | Class II | Unknown |
| SoftTip large | R-2414-15 HP/Philips | FDA UDI | Class II | Unknown |
| SoftTip small | RS-3512-9 Datex | FDA UDI | Class II | Unknown |
| Disposable Sensor | DN-2231-6 Nonin | FDA UDI | Class II | Unknown |
| 6050-0004-110 | 6050-0004-110 | FDA UDI | Class II | Active |
| SoftTip® medium | RM-3412 Ohmeda | FDA UDI | Class II | Unknown |
| MySign® S | wo/power supply FDA | FDA UDI | Class II | Active |
| SoftTip® small | RS-3211-31 MySign® FDA | FDA UDI | Class II | Unknown |
| FingerClip | F-3512-9 Datex | FDA UDI | Class II | Unknown |
| SoftTip large | R-3512-40 Datex | FDA UDI | Class II | Unknown |
| MySign® S | inkl. DA-2211-1 MySign® FDA | FDA UDI | Class II | Unknown |
| FingerClip | F-3262 Novametrix | FDA UDI | Class II | Unknown |
| SoftTip® medium | RM-2414-15 HP/Philips | FDA UDI | Class II | Unknown |
| MySign® S | incl. F-3211-12 MySign® FDA | FDA UDI | Class II | Unknown |
| Oxygen Sensor | OOMLF204-D | FDA UDI | Class II | Active |
| Disposable Sensor | DN-2211-6 OEM Nellcor | FDA UDI | Class II | Unknown |
| FingerClip | F-3512-40 AMC Datex | FDA UDI | Class II | Unknown |
| SoftTip® large | R-3211-31 MySign® FDA | FDA UDI | Class II | Unknown |
| Y-Sensor | Y-2217-9 OEM Nellcor | FDA UDI | Class II | Unknown |
| Mox2 | AA829-220 | FDA UDI | Class II | Active |
| FingerClip | F-3212-31 Nellcor | FDA UDI | Class II | Unknown |
| SoftTip® small | RS-2414-30 HP/Philips | FDA UDI | Class II | Unknown |
| FingerClip | F-3412-9 Ohmeda | FDA UDI | Class II | Unknown |
| Y-Sensor | Y-2257-9 OEM Datex | FDA UDI | Class II | Unknown |
| SoftTip small | RS-2414-15 HP/Philips | FDA UDI | Class II | Unknown |
| Oxygen Sensor | OOM204 | FDA UDI | Class II | Active |
| SoftTip® medium | RM-3222-12 BCI | FDA UDI | Class II | Unknown |
| SoftTip® medium | RM-3227 WEI Weinmann / grey | FDA UDI | Class II | Unknown |
| Oxygen Sensor | OOMLF103-1 | FDA UDI | Class II | Active |
| Oxygen Sensor | OOMLF106 | FDA UDI | Class II | Active |
| SoftTip small | RS-3412 Ohmeda | FDA UDI | Class II | Unknown |
| Oxygen Sensor | OOMLF103 | FDA UDI | Class II | Active |
| Oxygen Sensor | OOMLF202-1 | FDA UDI | Class II | Active |
| Oxygen Sensor | OOMLF105 | FDA UDI | Class II | Active |
| Y-Sensor | Y-2387 HP/Philips | FDA UDI | Class II | Unknown |
| Oxygen Sensor | OOM107 | FDA UDI | Class II | Active |
| Oxygen Sensor | OOM201 | FDA UDI | Class II | Active |
| Oxygen Sensor | OOMLF102-1 | FDA UDI | Class II | Active |
| FingerClip | F-2414-15 OEM HP/Philips | FDA UDI | Class II | Unknown |
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