Sunnex, Inc.
United StatesFDA applicant, unverified
Sunnex, Inc. is a medical device manufacturer, with 65 devices listed in FDA GUDID and FDA 510(k) (FDA Class I and II) and 2 FDA recalls as of 14 Nov 2026.
- Devices
- 65
- FDA recalls
- 2
Registry facts
- Registries
- FDA GUDID 63
- FDA 510(k) 2
- Device classes
- FDA Class I 54
- FDA Class II 11
- FDA recalls
At a glance
Market reach
- United States
- FDA recalls
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.
Catalogue
Search and filter all 65 devicesShowing 1-50 of 65
FDA recalls
FDA recall records list 2 recalls initiated by Sunnex, Inc., initiated on 2007-02-13. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 13 Feb 2007 Z-1100-2007 Unclassified (pre-2012) Terminated Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.
- 13 Feb 2007 Z-1101-2007 Unclassified (pre-2012) Terminated Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.
Frequently asked questions
How many devices does Sunnex, Inc. have in the registry?
The registry currently lists 65 devices for Sunnex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sunnex, Inc.'s devices?
Among its 50 most recently registered devices, Sunnex, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Sunnex, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Sunnex, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sunnex, Inc.?
FDA recall records list 2 recalls initiated by Sunnex, Inc., the most recent initiated on 13 Feb 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Sunnex, Inc. in the registry?
The most recently registered devices listed for Sunnex, Inc. include Celestial Star CS2050D-MRI, Leo Minor LMI-550, PF PF2006-32-UK and Leo Minor LMI-400.