Data / Medical devices / Finland / Mediracer Ltd.
Mediracer Ltd.: FDA-registered device maker in Oulu Kainuu, Finland, 1 510(k) clearance
Mediracer Ltd. is registered with the FDA (registration 3013246402) in Oulu Kainuu, Finland. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 25, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013246402
- Address
- Kasarmintie 13, Oulu Kainuu, Finland, 90130
- Owner or operator
- Mediracer Ltd. (10061237)
- Roles
- Manufacturer
- First device listed
- September 27, 2019
- Registered through
- 2026
- Brand names listed
- Mediracer NCS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Nerve Conduction Velocity Measurement | JXE | 2 | Manufacturer | accessdata.fda.gov |
| Electromyograph, Diagnostic | IKN | 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 |
|---|---|---|---|---|---|---|
| September 25, 2019 | K190536 | Mediracer NCS | JXE | Substantially Equivalent | Mediracer OY | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Nerve Conduction Velocity Measurement
- All makers of Electromyograph, Diagnostic
Updated September 25, 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.