Hemosonics LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000034476
Hemosonics LLC is a medical device manufacturer based in the United States, with 20 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II; EU Class A) as of 14 Nov 2026.
- Devices
- 20
- Registrations
- EUDAMED
Registry facts
- Registries
- FDA GUDID 11
- FDA 510(k) 6
- EUDAMED 5
- Device classes
- FDA Class II 12
- EU Class A 5
- Top EMDN categories
- Sites and related companies
- QbD RepS BV authorised representative
- Identifiers
- EUDAMED SRN US-MF-000034476
- DUNS 193921041
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- QbD RepS BVBE
What Hemosonics LLC makes
Hemosonics LLC makes coagulation analyser IVD devices for point-of-care and laboratory use, including the Quantra QPlus System and QStat Cartridge, which are line-powered instruments used to assess blood clotting function. The company also produces multiple coagulation factor IVD reagents and associated controls such as Qstat Control Level 1 and Level 2, as well as accessories like the Printer Kit WW.
These devices are classified as Class A and Class II medical devices and are listed in regulatory registries including Eudamed, the FDA 510(k) database, and the FDA UDI system. Hemosonics LLC is based in the United States.
Catalogue
Search and filter all 20 devicesCompany details
- EUDAMED SRN
- US-MF-000034476
- DUNS number
- 193921041
- EUDAMED status
- Active
- EUDAMED registered name
- Hemosonics LLC
- EUDAMED abbreviated name
- Hemosonics
- Registered address
- 4020, Stirrup Creek Drive, 27703, Durham, United States
- Phone
- +1(800)280-5589
- PRRC contact
- Deborah Winegar
Frequently asked questions
How many devices does Hemosonics LLC have in the registry?
The registry currently lists 20 devices for Hemosonics LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hemosonics LLC's devices?
Among its 20 most recently registered devices, Hemosonics LLC has devices listed in EUDAMED (5 devices), FDA 510(k) (6 devices) and FDA GUDID (11 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Hemosonics LLC's devices fall under?
Among its 20 most recently registered devices, the classes recorded for Hemosonics LLC's devices are Class II and IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from Hemosonics LLC in the registry?
The most recently registered devices listed for Hemosonics LLC include QStat Cartridge KIT (Box of 10), Quantra QPlus System KT-0034, Quantra QPlus System KT-0025 and Quantra QPlus System KT-0023.