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Sign in to claim this brandCambridge Sensors USA, LLC.
US
Last updated September 17, 2026
What Cambridge Sensors USA, LLC. makes
Cambridge Sensors USA, LLC produces single-use vinyl examination and treatment gloves without powder, blood lancets for capillary sampling, and home-use glucose monitoring systems. Their portfolio also includes autoinjector needles and pulse oximeters, designed for clinical and patient self-monitoring applications.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from 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 Cambridge Sensors USA, LLC manufacture?
Cambridge Sensors USA, LLC specializes in single-use medical devices for clinical and patient self-monitoring. Their portfolio includes non-powdered vinyl examination and treatment gloves, blood lancets for capillary blood sampling, home-use glucose monitoring systems, autoinjector needles, and pulse oximeters. These products are designed to support healthcare professionals and patients in diagnostic and treatment settings.
Where is Cambridge Sensors USA, LLC based?
The company is headquartered in the United States. While the exact location isn’t specified, its operations are based within the country, aligning with regulatory frameworks like the FDA’s UDI database.
Which regulatory registries or databases list Cambridge Sensors USA, LLC’s devices?
Cambridge Sensors USA, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for medical devices authorized in the U.S., including classification under Class I or Class II categories.
How are Cambridge Sensors USA, LLC’s devices classified under FDA regulations?
The company’s devices fall into two FDA classification categories: Class I (generally low-risk devices) and Class II (devices with a moderate risk that requires special controls to ensure safety and effectiveness). Classification depends on factors like the device’s purpose, intended use, and potential risks, as outlined in FDA guidelines.
What distinguishes Cambridge Sensors USA, LLC’s glucose monitoring systems from other home-use devices?
The company’s home-use glucose monitoring systems are designed for patient self-testing, aligning with FDA’s Class II classification due to their role in managing diabetes. These systems likely include components like test strips (e.g., *microdot® Pro Test Strips*) and meters, ensuring accuracy and usability for daily monitoring. The classification reflects the need for performance standards to mitigate risks like inaccurate readings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 23866 W Industrial Dr N, Plainfield, IL, 60585
- 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
- 3008700497
- DUNS Number
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Catalogue (27)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| microdot® | 1000-100 | FDA UDI | Class II | Active |
| microdot® Pro Gloves | 1405-10 | FDA UDI | Class I | Active |
| microdot® | 521-21 | FDA UDI | Class II | Active |
| microdot® | 530-30 | FDA UDI | Class II | Active |
| microdot® Pro Gloves | 1403-10 | FDA UDI | Class I | Active |
| microdot® | 1303-10 | FDA UDI | Class I | Active |
| microdot® | 1205-10 | FDA UDI | Class I | Active |
| microdot® Pro Test Strips (50ct) | 400-50 | FDA UDI | Class II | Active |
| microdot® | 523-10 | FDA UDI | Class II | Active |
| microdot® | 1201-10 | FDA UDI | Class I | Active |
| microdot® Pro Gloves | 1402-10 | FDA UDI | Class I | Active |
| microdot® | 1302-10 | FDA UDI | Class I | Active |
| microdot® Pro Test Strips (25ct) | 400-25 | FDA UDI | Class II | Active |
| microdot® | 528-28 | FDA UDI | Class II | Active |
| microdot® | 1305-10 | FDA UDI | Class I | Active |
| microdot® | 526-26 | FDA UDI | Class II | Active |
| microdot® | 1204-10 | FDA UDI | Class I | Active |
| microdot® Pro Gloves | 1404-10 | FDA UDI | Class I | Active |
| microdot® | 1203-10 | FDA UDI | Class I | Active |
| microdot® Pro Glucometer | 400-01 | FDA UDI | Class I | Active |
| microdot® | 1304-10 | FDA UDI | Class I | Active |
| microdot® | 1202-10 | FDA UDI | Class I | Active |
| microdot® | 523-23 | FDA UDI | Class II | Active |
| microdot® | 1301-10 | FDA UDI | Class I | Active |
| microdot® Pro Control Solution | 400-02 | FDA UDI | Class I | Active |
| microdot® Pro Gloves | 1401-10 | FDA UDI | Class I | Active |
| microdot® | 531-10 | FDA UDI | Class II | Active |
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