Data / Medical devices / Sweden / Rossix AB
Rossix AB: FDA-registered device maker in Molndal Vastra Gotaland, Sweden, 1 510(k) clearance
Rossix AB is registered with the FDA (registration 3004075036) in Molndal Vastra Gotaland, Sweden. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004075036
- Address
- Taljegardsgatan 3B, Molndal Vastra Gotaland, Sweden, 43153
- Owner or operator
- Rossix AB (10090697)
- Roles
- Manufacturer
- First device listed
- April 30, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Test, Qualitative And Quantitative Factor Deficiency | GGP | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 13, 2023 | K230852 | HemosIL Chromogenic Factor IX | GGP | Substantially Equivalent | Instrumentation Laboratory Company | accessdata.fda.gov |
Compare with other makers
Updated December 13, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.