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Sign in to claim this brandSolaris Medical Technology, Inc.
US
Last updated May 25, 2026
What Solaris Medical Technology, Inc. makes
Solaris Medical Technology, Inc. manufactures reusable pulse oximeter probes and handheld pulse oximeters, including models with sensor accessories. Their product line also includes reusable and disposable blood pressure cuffs, as well as reusable adult finger sensors compatible with their devices.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. Their products are based in the United States and comply with relevant U.S. regulatory requirements for medical devices.
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 Solaris Medical Technology, Inc. manufacture?
Solaris Medical Technology, Inc. specializes in reusable pulse oximeter probes and handheld pulse oximeters, such as the SOLARIS NT1/NT1A models with sensor accessories. Their product line also includes reusable and disposable blood pressure cuffs, as well as reusable adult finger sensors compatible with their pulse oximeters, like the NELLCOR-compatible T100A-090103 sensor. These devices are designed for monitoring oxygen saturation and blood pressure in clinical settings.
Where is Solaris Medical Technology, Inc. based?
Solaris Medical Technology, Inc. is headquartered in the United States. The company’s devices are developed and manufactured there, adhering to U.S. regulatory standards for medical device safety and performance.
Which regulatory registries list Solaris Medical Technology’s devices?
Solaris Medical Technology’s devices are included in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries track medical devices that have undergone the necessary regulatory pathways to demonstrate compliance with U.S. requirements before entering the market.
How are Solaris Medical Technology’s devices classified under FDA regulations?
Solaris Medical Technology’s devices fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls—such as performance standards, post-market surveillance, or labeling requirements—to ensure their safety and effectiveness. Class II devices typically require a 510(k) premarket submission to demonstrate substantial equivalence to a legally marketed predicate device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- 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
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- DUNS Number
- 527945351
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Avante/Pacific | NSPH3020 | FDA UDI | Class II | Active |
| Solaris | T100A-090087 | FDA UDI | Class II | Active |
| Solaris | T100A-300087 | FDA UDI | Class II | Active |
| Solaris | T100P-090087 | FDA UDI | Class II | Active |
| Solairs | S200A-300101 | FDA UDI | Class II | Active |
| Solairs | T100A-300110 | FDA UDI | Class II | Active |
| Solaris Nt1 And Nt1a Handheld Pulse Oximeters With Sensor Accessories | K073249 | FDA 510(k) | Class II | Active |
| Nellcor Compatible Reusable Spo2 Soft-Finger Sensor, Model T100a-090103 | K100077 | EUDAMEDFDA 510(k) | Class II | Active |
| Solaris Models Nt1 And Nt1a Handheld Pulse Oximeters With Sensor Accessories | K092950 | FDA 510(k) | Class II | Active |
| Solaris Reusable And Disposable Blood Pressure Cuffs | K101972 | FDA 510(k) | Class II | Active |
| Solaris Compatible Reusable Adult Spo2 Finger Sensors, Models S100a-090103 And 300103, S200a-090101 And 300101 | K061931 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Solaris Medical Technology, Inc. Shenzhen Guangdong · CN FEI 3006552505