Data / Medical devices / Sweden / Integration Diagnostics Sweden AB
Integration Diagnostics Sweden AB: FDA-registered device maker in Goteborg Vastra Gotaland, Sweden, 1 510(k) clearance
Integration Diagnostics Sweden AB is registered with the FDA (registration 3013206323) in Goteborg Vastra Gotaland, Sweden. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 7, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013206323
- Address
- Furstenbergsgatan 4, Goteborg Vastra Gotaland, Sweden, 41664
- Owner or operator
- Integration Diagnostics Sweden AB (10054105)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 11, 2017
- Registered through
- 2026
- Brand names listed
- IS3, IS4, Locking screwdriver, MDI MulTipeg, MulTipeg, MulTipeg Driver, Osseo 100, Osseo 100+ and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | 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 |
|---|---|---|---|---|---|---|
| January 7, 2016 | K143445 | Tellos ISQ Buddy | EKX | Substantially Equivalent | Tellos Medical AB | accessdata.fda.gov |
Compare with other makers
Updated January 7, 2016. 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.