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Sign in to claim this brandNonin Medical, Inc.
United States·US-MF-000008228
Last updated September 17, 2026
What Nonin Medical, Inc. makes
Nonin Medical, Inc. manufactures pulse oximeters, including single-use and reusable probes, as well as line-powered and handheld models. Their portfolio also includes cerebral oximeters and associated single-use sensors, along with reusable electrical cables and lead holders for medical device connections.
The company’s devices are classified as Class I, Class II, and Class IIb under regulatory frameworks. Products are listed in eudamed, FDA’s 510(k) and UDI registries, reflecting their compliance with European and US medical device regulations. The manufacturer 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 Nonin Medical, Inc. manufacture?
Nonin Medical, Inc. specializes in pulse oximetry devices, including single-use and reusable probes, as well as line-powered and handheld pulse oximeters. Their portfolio also covers cerebral oximeters and their associated single-use sensors, along with reusable electrical cables and lead holders for medical device connections. These products are designed for monitoring oxygen saturation and cerebral oxygenation in clinical settings.
Where is Nonin Medical, Inc. based, and what regulatory frameworks apply to their devices?
Nonin Medical, Inc. is based in the United States. Their devices fall under regulatory classification as Class I, Class II, and Class IIb, which are common categorizations for low-to-moderate-risk medical devices. These classifications determine the level of oversight and compliance requirements, such as pre-market notifications (e.g., FDA’s 510(k)) or conformity assessments for European markets.
Which regulatory registries list Nonin Medical, Inc.’s devices?
Nonin Medical, Inc.’s devices are listed in key regulatory databases, including eudamed (the European database for medical devices), the FDA’s 510(k) registry (for premarket notifications in the U.S.), and the FDA’s UDI (Unique Device Identification) database. These registries ensure transparency and traceability of their products under both European and U.S. medical device regulations.
How are Nonin Medical, Inc.’s devices classified under regulatory standards?
Nonin Medical, Inc.’s devices are classified as Class I (generally low-risk, like reusable cables), Class II (moderate-risk, such as reusable pulse oximeter probes), and Class IIb (higher-risk, including advanced monitors like handheld oximeters or cerebral oximeters). Classification determines the regulatory pathway—e.g., Class IIb devices may require more rigorous pre-market evaluations (like FDA’s 510(k)) or conformity assessments (e.g., EU MDR) to ensure safety and performance.
Why do some of Nonin Medical, Inc.’s devices appear in both FDA and EU registries?
Nonin Medical, Inc.’s devices appear in both FDA (U.S.) and eudamed (EU) registries because they are marketed in multiple regions with distinct regulatory requirements. The U.S. FDA’s 510(k) and UDI systems track devices cleared for sale in the U.S., while eudamed records devices that comply with EU Medical Device Regulations (MDR) or previous directives. Listing in both ensures compliance with local laws while reflecting the company’s global distribution of their pulse oximetry and cerebral monitoring solutions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 13700, 1st Avenue North, Plymouth, United States
- Website
- nonin.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Dan LaBelle
- EUDAMED SRN
- US-MF-000008228
- FDA FEI Number
- 2183646
- DUNS Number
- —
Catalogue (371)
Page 2 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nonin | 8000FI-30 | FDA UDI | Class II | Active |
| Nonin | 8000SL | FDA UDI | Class II | Active |
| Nonin | X-100SP-3 | FDA UDI | Class II | Active |
| Nonin | X-100SP-1 | FDA UDI | Class II | Active |
| Nonin | 8000J-WO2 | FDA UDI | Class II | Active |
| Nonin | 7500SC | FDA UDI | Class II | Active |
| Palmsat Handheld Oximeter | 2500, 8000SL | FDA UDI | Class II | Active |
| Nonin | 8000AP-WA | FDA UDI | Class II | Active |
| Nonin | UNI-EXT-9 | FDA UDI | Class II | Active |
| Nonin | 3150 WristOx2 | FDA UDI | Class II | Active |
| Nonin | 8000AA-WO2 | FDA UDI | Class II | Active |
| Nonin | 8000FI-20 | FDA UDI | Class II | Active |
| Nonin | 8003CA | FDA UDI | Class II | Active |
| Nonin | 9590 | FDA UDI | Class II | Active |
| Nonin | 8604E-J | FDA UDI | Class II | Active |
| Nonin | LS1 PS | FDA UDI | Class II | Active |
| Nonin | 9500 | FDA UDI | Class II | Active |
| Nonin | 9600 | FDA UDI | Class II | Active |
| Nonin | 8500 | FDA UDI | Class II | Active |
| Nonin | 8000CA | FDA UDI | Class II | Active |
| Nonin | INT-2XX | FDA UDI | Class II | Active |
| Nonin | 6000CA | FDA UDI | Class II | Active |
| Nonin | 8000FC-20 | FDA UDI | Class II | Active |
| Nonin | INT-100 | FDA UDI | Class II | Active |
| Nonin | 8000SM-WO | FDA UDI | Class II | Active |
| Nonin | 1062232 | FDA UDI | Class II | Active |
| Nonin | 9840AAT | FDA UDI | Class II | Active |
| Nonin | 8000SM-3 | FDA UDI | Class II | Active |
| Nonin | 7600TC-3 | FDA UDI | Class II | Active |
| Nonin | 9590 | FDA UDI | Class II | Active |
| Nonin | 3100I-DS | FDA UDI | Class II | Active |
| Nonin | X-100HH | FDA UDI | Class II | Active |
| Nonin | LS1R-9R | FDA UDI | Class II | Active |
| Nonin | 7600PA | FDA UDI | Class II | Active |
| Nonin | UNI-EXT-3 | FDA UDI | Class II | Active |
| Nonin | 7500SC | FDA UDI | Class II | Active |
| Nonin | 8001J | FDA UDI | Class II | Active |
| Nonin | LS1 PS | FDA UDI | Class II | Active |
| Nonin | 8000AA-WA | FDA UDI | Class II | Active |
| Nonin | 7000I | FDA UDI | Class II | Active |
| Nonin | 7600PA Sensor Lock | FDA UDI | Class II | Active |
| Nonin | 8000SL-WO2 | FDA UDI | Class II | Active |
| Nonin | 8000SM-WO2 | FDA UDI | Class II | Active |
| Nonin | 8000J, 20CM | FDA UDI | Class II | Active |
| Nonin | 7500PS | FDA UDI | Class II | Active |
| Nonin | 2500B | FDA UDI | Class II | Active |
| Nonin | X-100SP-6 | FDA UDI | Class II | Active |
| Nonin | 8000H | FDA UDI | Class II | Active |
| Nonin | 8000SS | FDA UDI | Class II | Active |
| Nonin | 2500A | FDA UDI | Class II | Active |
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Nonin Medical, Inc. has four recall records initiated between October 11, 2007, and September 29, 2016, all of which are marked as terminated. The recalls involved issues such as a potential overheating malfunction in a component of a POD, signal loss in regional oximetry sensors during use with diaphoretic patients, incorrect pulse oximetry boards in handheld pulse oximeters, and mislabeled devices displaying an incorrect model number.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 29, 2016 | Z-1690-2017 | — | terminated | Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature. |
| Nov 25, 2014 | Z-0901-2015 | — | terminated | Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported. |
| Oct 23, 2009 | Z-0458-2010 | — | terminated | A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the potential to cause a burn if the POD is in direct contact with the patient. |
| Oct 11, 2007 | Z-0843-2008 | — | terminated | Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500. |