Data / Medical devices / Sweden / Circius Pharma AB
Circius Pharma AB: FDA-registered device maker in Askim Vastra Gotaland, Sweden, 2 510(k) clearances
Circius Pharma AB is registered with the FDA (registration 3021916254) in Askim Vastra Gotaland, Sweden. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 30, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021916254
- Address
- 34-36 Sodra Langebergsgatan, Askim Vastra Gotaland, Sweden, 43632
- Owner or operator
- Circius Pharma AB (10083659)
- Roles
- Manufacturer
- First device listed
- March 4, 2022
- Registered through
- 2026
- Brand names listed
- Otovent AutoInflatoin Kit, Tinearity
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Inflation, Middle Ear | MJV | U | Manufacturer | accessdata.fda.gov |
| Masker, Tinnitus | KLW | 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 |
|---|---|---|---|---|---|---|
| June 30, 2023 | K223694 | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | KLW | Substantially Equivalent | Duearity AB | accessdata.fda.gov |
| October 5, 1992 | K920840 | OTOVENT | MJV | Substantially Equivalent | Abigo Medical AB | accessdata.fda.gov |
Compare with other makers
Updated June 30, 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.