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US
Last updated May 25, 2026
What OSI OPTOELECTRONICS, INC. makes
OSI Optoelectronics, Inc. manufactures single-use and reusable pulse oximeter probes, as well as single-use sensor holders. The company also produces reusable electrical-only medical device connection cables, including products such as the BluSat, Dolphin, and TruLink lines.
The company is based in the United States and its portfolio consists of Class II medical devices. These products are listed in the FDA UDI database.
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 OSI Optoelectronics, Inc. manufacture?
OSI Optoelectronics, Inc. specializes in the production of pulse oximeter probes, which are available in both single-use and reusable formats. Additionally, the company manufactures single-use sensor holders and reusable electrical-only medical device connection cables. These offerings include specific product lines such as BluSat, Dolphin, and TruLink.
Where is OSI Optoelectronics, Inc. located?
OSI Optoelectronics, Inc. is based in the United States. This location serves as the primary base for the company's manufacturing operations and regulatory reporting activities.
How are the medical devices from OSI Optoelectronics, Inc. classified?
The medical devices manufactured by OSI Optoelectronics, Inc. are classified as Class II devices. This classification is based on the regulatory framework applied to their portfolio of pulse oximeter probes, sensor holders, and connection cables.
Where can I find the regulatory listings for these devices?
The devices produced by OSI Optoelectronics, Inc. are listed in the FDA UDI database. This registry provides transparency and identification for the company's medical products, including their various probe and cable lines, in accordance with regulatory requirements.
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
- 612770974
Catalogue (35)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BluSat | 4343 | FDA UDI | Class II | Active |
| Dolphin | 2311 | FDA UDI | Class II | Active |
| Dolphin | 3312-V | FDA UDI | Class II | Active |
| Dolphin | 2312 | FDA UDI | Class II | Active |
| BluSat | 4343 | FDA UDI | Class II | Active |
| Dolphin | 3312-F | FDA UDI | Class II | Active |
| BluSat | 4041 | FDA UDI | Class II | Active |
| TruLink | 015-0665-00 | FDA UDI | Class II | Active |
| BluSat | 1293 | FDA UDI | Class II | Active |
| TruLink | 015-0666-00 | FDA UDI | Class II | Active |
| BluSat | 4342 | FDA UDI | Class II | Active |
| BluSat | 4241 | FDA UDI | Class II | Active |
| BluSat | 4441 | FDA UDI | Class II | Active |
| TruLink | 015-0662-00 | FDA UDI | Class II | Active |
| TruLink | 015-0667-00 | FDA UDI | Class II | Active |
| BluSat | 4341 | FDA UDI | Class II | Active |
| TruLink | 015-0661-00 | FDA UDI | Class II | Active |
| TruLink | 015-0663-00 | FDA UDI | Class II | Active |
| BluSat | 1295 | FDA UDI | Class II | Active |
| Dolphin | 2313 | FDA UDI | Class II | Active |
| Dolphin | 2314 | FDA UDI | Class II | Active |
| TruLink | 015-0660-00 | FDA UDI | Class II | Active |
| BluSat | 4042 | FDA UDI | Class II | Active |
| Dolphin | 2010 | FDA UDI | Class II | Active |
| Dolphin | 3313-C | FDA UDI | Class II | Active |
| BluSat | 1295 | FDA UDI | Class II | Active |
| BluSat | 4342 | FDA UDI | Class II | Active |
| TruLink | 015-0664-00 | FDA UDI | Class II | Active |
| BluSat | 4344 | FDA UDI | Class II | Active |
| Dolphin | 3314-C | FDA UDI | Class II | Active |
| Dolphin | 3311-F | FDA UDI | Class II | Active |
| BluSat | 4344 | FDA UDI | Class II | Active |
| Dolphin | 2210 | FDA UDI | Class II | Active |
| BluSat | 4341 | FDA UDI | Class II | Active |
| Dolphin | 3311-V | FDA UDI | Class II | Active |
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