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Sign in to claim this brandSunnex, Inc.
US
Last updated May 23, 2026
What Sunnex, Inc. makes
Sunnex, Inc. manufactures medical lighting devices, including fixed examination and treatment room lights, mobile examination and treatment room lights, and operating room lights. Their product line includes models such as Celestial Star, Leo Minor, PF, and Tri Star.
These devices are regulated as Class I and Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries. The company 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 type of products does Sunnex, Inc. manufacture?
Sunnex, Inc. manufactures medical lighting devices, including fixed and mobile examination/treatment room lights and operating room lights, such as Celestial Star and Leo Minor, because these are listed as example devices.
Where is Sunnex, Inc. based?
Sunnex, Inc. is based in the US, as indicated by the country listed in the company information.
Which registries list Sunnex, Inc.'s devices?
Sunnex, Inc.'s devices are listed in the FDA 510(k) and FDA UDI registries, because these are the registries mentioned in the company data.
How are Sunnex, Inc.'s devices classified?
Sunnex, Inc.'s devices are classified as Class I and Class II medical devices, because these are the device classes specified in the company information.
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
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Catalogue (65)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Celestial Star | CS2050W | FDA UDI | Class I | Active |
| Celestial Star | CS2050M-MRI | FDA UDI | Class I | Active |
| Tri Star | TS2015M-E | FDA UDI | Class I | Active |
| Leo Minor | LMI-700-EU | FDA UDI | Class II | Active |
| Pf | PF2015-44-PI | FDA UDI | Class I | Active |
| Celestial Star | CSLED-W-HW | FDA UDI | Class I | Active |
| Celestial Star | CSLED-M | FDA UDI | Class I | Active |
| Pf | PF2017-44 | FDA UDI | Class I | Active |
| Celestial Star | CSLED-C39 | FDA UDI | Class I | Active |
| Celestial Star | CS2050M-MRI-E | FDA UDI | Class I | Active |
| Pf | PF28010 | FDA UDI | Class I | Active |
| Celestial Star | CSLED-C | FDA UDI | Class I | Active |
| Celestial Star | CS2050M-E | FDA UDI | Class I | Active |
| Accuratecare I & Accuratecare Ii | K851511 | FDA 510(k) | Class II | Active |
| Leo Minor | K142984 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Sunnex, Inc. has two recall records, both initiated on 2007-02-13. Both recalls are listed with a status of terminated. The filed reason for the recalls states that a surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.
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 |
|---|---|---|---|---|
| Feb 13, 2007 | Z-1101-2007 | — | terminated | Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder. |
| Feb 13, 2007 | Z-1100-2007 | — | terminated | Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder. |