Sienco, Inc.
United StatesFDA applicant, unverified FDA FEI 1719400
Sienco, Inc. is a medical device manufacturer, with 18 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 14 Nov 2026.
- Devices
- 18
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 13
- FDA 510(k) 5
- Device classes
- FDA Class II 18
- Identifiers
- FDA FEI 1719400
- DUNS 064039514
At a glance
Market reach
- United States
- FDA FEI
Catalogue
Search and filter all 18 devicesCompany details
- FDA FEI number
- 1719400
- DUNS number
- 064039514
- Address
- 5721 Arapahoe Ave., Boulder, CO, 80303
- info@sienco.com
- Phone
- 303-420-1148
Frequently asked questions
How many devices does SIENCO, INC. have in the registry?
The registry currently lists 18 devices for SIENCO, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list SIENCO, INC.'s devices?
Among its 18 most recently registered devices, SIENCO, INC. has devices listed in FDA 510(k) (5 devices) and FDA GUDID (13 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do SIENCO, INC.'s devices fall under?
Among its 18 most recently registered devices, the classes recorded for SIENCO, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from SIENCO, INC. in the registry?
The most recently registered devices listed for SIENCO, INC. include Sonoclot® Coagulation & Platelet Function Analyzer DP-2951, Sonoclot® aiACT Kit 800-0442, Sonoclot® gbACT+ Kit 800-0411 and Sonoclot® aiACT Kit 800-0441.