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US
Last updated May 30, 2026
What OXIMETER PLUS, INC. makes
Oximeter Plus, Inc. manufactures pulse oximeters, which are non-invasive devices used to measure blood oxygen saturation levels and pulse rate. These devices are primarily designed for clinical and home monitoring applications, providing real-time data on a patient’s oxygenation status.
The company’s pulse oximeters fall under FDA Class II regulation and are listed in the FDA’s Unique Device Identifier (UDI) database. The devices are intended for use in the United States, adhering to applicable medical device compliance standards.
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 Oximeter Plus, Inc. manufacture?
Oximeter Plus, Inc. specializes in pulse oximeters, which are non-invasive devices used to monitor blood oxygen saturation (SpO₂) and pulse rate. These devices are primarily intended for clinical and home use to provide real-time data on a patient’s oxygenation levels.
Where is Oximeter Plus, Inc. based?
Oximeter Plus, Inc. is based in the United States. The company’s devices are designed and manufactured with compliance to U.S. medical device regulations in mind.
Which regulatory registries or databases list Oximeter Plus, Inc.’s devices?
Oximeter Plus, Inc.’s pulse oximeters are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring traceability and compliance.
How are Oximeter Plus, Inc.’s devices classified by regulatory authorities?
Oximeter Plus, Inc.’s pulse oximeters fall under FDA Class II classification. This classification is assigned based on the device’s risk level and intended use, requiring compliance with specific regulatory controls to ensure safety and performance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- 516-626-6226
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 829005607
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Oximeter Plus | Premier | FDA UDI | Class II | Active |
| Oximeter Plus | Elite | FDA UDI | Class II | Active |
| Oximeter Plus | QuickCheck Pro | FDA UDI | Class II | Active |
| Oximeter Plus | QuickCheck | FDA UDI | Class II | Active |
| Oximeter Plus | C21 | FDA UDI | Class II | Active |
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