Data / Medical devices / Poland / Getinge IC Production Poland sp. z o.o.
Getinge IC Production Poland sp. z o.o.: FDA-registered device maker in Plewiska Wielkopolskie, Poland, 2 510(k) clearances
Getinge IC Production Poland sp. z o.o. is registered with the FDA (registration 3012068831) in Plewiska Wielkopolskie, Poland. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 12, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012068831
- Address
- Szkolna 30, Plewiska Wielkopolskie, Poland, 62-064
- Owner or operator
- Getinge (9057664)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 15, 1992
- Registered through
- 2026
- Brand names listed
- GSS610N10; GSS610N14, and GSS610N15 Steam Sterilizers, GSS610N21 Series Steam Sterilizer, GSS67N Steam Sterilizer, Getinge 400HC-E/500HC-E Series Steam Sterilizer, Getinge Aquadis PCU (Getinge Disinfection AB only), Hospital wire mesh tray, Model 1100 - Lumen Tray with Accessory Kit, Model 1100 - Lumen tray only and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Contract manufacturer | accessdata.fda.gov |
| Sterilizer, Steam | FLE | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| March 12, 2013 | K122071 | GETINGE 400HC-E / SERIES STEAM STERILIZER | FLE | Substantially Equivalent | Getinge Sourcing, LLC | accessdata.fda.gov |
| May 31, 2012 | K120441 | GETINGE 700HC-E SERIES STEAM STERILIZER | FLE | Substantially Equivalent | Getinge Sourcing, LLC | accessdata.fda.gov |
Compare with other makers
Updated March 12, 2013. 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.