Data / Medical devices / Sweden / Biovica International AB
Biovica International AB: FDA-registered device maker in Uppsala, Sweden, 1 510(k) clearance
Biovica International AB is registered with the FDA (registration 3008629194) in Uppsala, Sweden. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008629194
- Address
- Uppsala Science Park Dag Hammarskjolds vag 54 B, Uppsala, Sweden, 75237
- Owner or operator
- BIOVICA International AB (10085854)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 31, 2022
- Registered through
- 2026
- Brand names listed
- DiviTum, DiviTumTKa
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Thymidine Kinase Activity | QTE | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| July 29, 2022 | K202852 | DiviTum TKa | QTE | Substantially Equivalent | Biovica International AB | accessdata.fda.gov |
Updated July 29, 2022. 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.