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US
Last updated May 25, 2026
What Soberlink Healthcare, LLC makes
Soberlink Healthcare, LLC manufactures alcohol breath analyzers, specifically the SOBERLINK device and the Soberlink Cellular Device with Sober Sky Web Portal.
The company's products are Class I devices listed in the FDA 510(k) and FDA UDI registries, and the company is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Soberlink Healthcare, LLC manufacture?
Soberlink Healthcare, LLC manufactures alcohol breath analyzers, specifically the SOBERLINK device and the Soberlink Cellular Device with Sober Sky Web Portal, which are designed to monitor alcohol consumption.
Where is Soberlink Healthcare, LLC based?
Soberlink Healthcare, LLC is based in the United States, as indicated by the country information provided in the device data.
Which regulatory registries list Soberlink Healthcare's devices?
Soberlink Healthcare's devices are listed in the FDA 510(k) and FDA UDI registries, which are regulatory databases for medical devices in the United States.
How are Soberlink Healthcare's devices classified?
Soberlink Healthcare's devices are classified as Class I medical devices, which are the lowest risk category in the FDA's classification system for medical devices.
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
- 079871438
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Soberlink | SOBERLINK CELLULAR CATM | FDA UDI | Class I | Active |
| Soberlink | SOBERLINK CONNECT ST - 08 | FDA UDI | Class I | Active |
| Soberlink | SOBERLINK Connect - 01 | FDA UDI | Class I | Active |
| Soberlink | SOBERLINK GSM2 - 02 | FDA UDI | Class I | Active |
| Soberlink | SOBERLINK LTE - 06 | FDA UDI | Class I | Active |
| Soberlink | SOBERLINK GSM1 REFURB - 05 | FDA UDI | Class I | Unknown |
| Soberlink | SOBERLINK 7.0 | FDA UDI | Class I | Active |
| Soberlink Cellular Device and Sober Sky Web Portal | K160613 | FDA 510(k) | Class I | Active |
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