Data / Medical devices / Poland / Inoris Medical SP. Z O.O.
Inoris Medical SP. Z O.O.: FDA-registered device maker in Kowary Dolnoslaskie, Poland, 1 510(k) clearance
Inoris Medical SP. Z O.O. is registered with the FDA (registration 3010806663) in Kowary Dolnoslaskie, Poland. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 24, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010806663
- Address
- ul. Zmkowa 9, Kowary Dolnoslaskie, Poland, 58530
- Owner or operator
- Inoris Medical Sp. z o.o. (10046303)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 3, 2014
- Registered through
- 2026
- Brand names listed
- Adult Biteguard, Clip-On Biteguard, Gastroguard, PYLANT MONITOR, Pediatric Biteguard, Scanhead protection cover, Soft Adult Biteguard, Tubeguard
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cuff, Tracheal Tube, Inflatable | BSK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | 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 |
|---|---|---|---|---|---|---|
| February 24, 2020 | K191858 | Pylant Monitor | BSK | Substantially Equivalent | Kal-Med, LLC | accessdata.fda.gov |
Compare with other makers
Updated February 24, 2020. 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.