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Sign in to claim this brandLifescan Europe
US
Last updated May 23, 2026
What Lifescan Europe makes
Lifescan Europe manufactures blood glucose monitoring systems for home use and point-of-care settings, including models such as OneTouch Verio Reflect, OneTouch Ultramini, OneTouch Ultrasoft, OneTouch Verio Flex, OneTouch Ultra Blue, and OneTouch Ultra2. The company also produces manual blood lancing devices in both reusable and single-use forms, along with lancing device tips and glucose IVD controls and electrometry kits.
The company’s portfolio includes Class I and Class II devices listed in the FDA 510(k) and FDA UDI registries. Lifescan Europe is based in the United States.
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 Lifescan Europe manufacture?
Lifescan Europe primarily manufactures blood glucose monitoring systems for home use and point-of-care settings, including models like OneTouch Verio Reflect and OneTouch Ultra2. The company also produces manual blood lancing devices in both reusable and single-use forms, along with lancing device tips, glucose IVD controls, and electrometry kits. These products are designed for glucose monitoring and sample collection in clinical and home environments.
Where is Lifescan Europe based?
Lifescan Europe is based in the United States. This is the country of origin listed for the company in the regulatory data, which is relevant for understanding the jurisdiction under which its devices are registered and marketed.
In which regulatory registries are Lifescan Europe’s devices listed?
Lifescan Europe’s devices are listed in the FDA 510(k) and FDA UDI registries. The 510(k) listing indicates that the company has submitted premarket notifications for its devices, while the UDI (Unique Device Identification) registry reflects compliance with tracking requirements for medical devices in the U.S. market.
How are Lifescan Europe’s devices classified?
Lifescan Europe’s devices are classified as both Class I and Class II medical devices. Class I devices are subject to the lowest level of regulatory control, while Class II devices require additional controls such as special testing or performance standards. This classification determines the regulatory pathway and oversight each device must follow.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (78)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OneTouch Verio Blood Glucose Monitoring System. | 024041 | FDA UDI | Class II | Active |
| OneTouch Verio Flex | 024044 | FDA UDI | Class II | Active |
| OneTouch Ultra | 010-458 | FDA UDI | Class I | Active |
| OneTouch Verio IQ | 022-268 | FDA UDI | Class II | Active |
| OneTouch Verio | 011-817 | FDA UDI | Class II | Active |
| OneTouch Verio Reflect | 023-900 | FDA UDI | Class II | Active |
| OneTouch Verio | 022-978 | FDA UDI | Class II | Active |
| OneTouch Ultra Blue | 020-994 | FDA UDI | Class II | Active |
| OneTouch SureSoft | 021-141 | FDA UDI | Class II | Active |
| OneTouch Ultrasoft | 011-423 | FDA UDI | Class II | Active |
| OneTouch Verio | 024-174 | FDA UDI | Class II | Active |
| OneTouch Verio Reflect | 023-899 | FDA UDI | Class II | Active |
| OneTouch Verio Flex | 024-267 | FDA UDI | Class II | Active |
| OneTouch Ultramini | 021-211 | FDA UDI | Class II | Active |
| OneTouch Ultra Blue | 011-424 | FDA UDI | Class II | Active |
| OneTouch Ultra2 | 024-046 | FDA UDI | Class II | Active |
| OneTouch Ultra2 | 022-965 | FDA UDI | Class II | Active |
| OneTouch Verio IQ | 022-267 | FDA UDI | Class II | Active |
| OneTouch Ultra2 | 021-098 | FDA UDI | Class II | Active |
| OneTouch Ultra Blue | 022-896 | FDA UDI | Class II | Active |
| OneTouch Ping | 023-049 | FDA UDI | Class II | Active |
| OneTouch Ultra Blue | 020-963 | FDA UDI | Class II | Active |
| OneTouch Verio | 023-061 | FDA UDI | Class II | Active |
| OneTouch Ultra Blue | 022-895 | FDA UDI | Class II | Active |
| OneTouch Ultramini | 021-924 | FDA UDI | Class II | Active |
| OneTouch Ultra Plus | 024-271 | FDA UDI | Class II | Active |
| OneTouch Verio Flex Blood Glucose Monitoring System | K150214 | FDA 510(k) | Class II | Active |
| OneTouch Ultra Plus Flex Blood Glucose Monitoring System | K151611 | FDA 510(k) | Class II | Active |
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