Data / Medical devices / Sweden / Toul Meditech AB
Toul Meditech AB: FDA-registered device maker in Vasteras Vastmanland, Sweden, 3 510(k) clearances
Toul Meditech AB is registered with the FDA (registration 3012992602) in Vasteras Vastmanland, Sweden. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated May 10, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012992602
- Address
- Tunbytorpsgatan 31, Vasteras Vastmanland, Sweden, 72137
- Owner or operator
- Toul Meditech AB (10052761)
- Roles
- Manufacturer
- First device listed
- October 3, 2016
- Registered through
- 2026
- Brand names listed
- Operio, SteriStay, SurgiCube
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Air Filter Portable Apparatus | ORC | 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 |
|---|---|---|---|---|---|---|
| May 10, 2019 | K190027 | SteriStay | ORC | Substantially Equivalent | Toul Meditech AB | accessdata.fda.gov |
| September 28, 2017 | K163455 | SurgiCube | ORC | Substantially Equivalent | Surgicube International B.V. | accessdata.fda.gov |
| July 20, 2016 | K153498 | Operio | ORC | Substantially Equivalent | Toul Meditech AB | accessdata.fda.gov |
Updated May 10, 2019. 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.