Optim LLC
United StatesFDA applicant, unverified FDA FEI 1218141
Optim LLC is a medical device manufacturer, with 20 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 13 Nov 2026.
- Devices
- 20
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 14
- FDA 510(k) 6
- Device classes
- FDA Class II 20
- Identifiers
- FDA FEI 1218141
- DUNS 052927001
At a glance
Market reach
- United States
- FDA FEI
Catalogue
Search and filter all 20 devicesCompany details
- FDA FEI number
- 1218141
- DUNS number
- 052927001
- Address
- 64 TECHNOLOGY PARK RD., Sturbridge, MA, 01566
Frequently asked questions
How many devices does OPTIM LLC have in the registry?
The registry currently lists 20 devices for OPTIM LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list OPTIM LLC's devices?
Among its 20 most recently registered devices, OPTIM LLC has devices listed in FDA 510(k) (6 devices) and FDA GUDID (14 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do OPTIM LLC's devices fall under?
Among its 20 most recently registered devices, the classes recorded for OPTIM LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from OPTIM LLC in the registry?
The most recently registered devices listed for OPTIM LLC include ENTity XL Nasopharyngoscope F014721, ENTity SDXL 45X Nasopharyngoscope F015050, ENTity SD Nasopharyngoscope F014766 and Entity XL USB Nasopharyngoscope F016211.