Data / Medical devices / Poland / RR Donnelley GTS Poland Sp. z o.o.
RR Donnelley GTS Poland Sp. z o.o.: FDA-registered device maker in Lodz Lodzkie, Poland, 6 510(k) clearances and 1 PMA approval
RR Donnelley GTS Poland Sp. z o.o. is registered with the FDA (registration 3008606429) in Lodz Lodzkie, Poland. It lists 5 device types. The FDA files 6 510(k) clearances and 1 PMA approval under its listings, the newest dated June 12, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008606429
- Address
- Zakladowa 90/92, Lodz Lodzkie, Poland, 92-402
- Owner or operator
- RR Donnelley GTS Poland Sp. z o.o. (10033813)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 7, 2010
- Registered through
- 2026
- Brand names listed
- Ascensia Contour Blood Glucose Meter, Model 7151;, Contour Next USB, Flash 3, FreeStyle Libre 2 Flash Glucose Monitoring System, Freestyle InsuLinx, Freestyle Libre Flash Glucose Monitoring System, LFR - Glucose dehydrogenase, glucose NBW - System, test, blood glucose, over the counter, Next EZ and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems | QLG | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated | PZE | 3 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Contract manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Contract manufacturer, Exporter to the US, 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 12, 2020 | K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | QLG | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| June 28, 2012 | K121087 | CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Bayer Healthcare | accessdata.fda.gov |
| March 29, 2012 | K120568 | FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| May 14, 2010 | K092602 | FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System | NBW | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| September 11, 2006 | K062058 | ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 | NBW | Substantially Equivalent | Bayer Healthcare | accessdata.fda.gov |
| May 27, 2005 | K051213 | PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS | NBW | Substantially Equivalent | Abbott Laboratories, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 27, 2017 | P160030 | Freestyle Libre Flash Glucose Monitoring System | PZE | 54 | September 1, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Dehydrogenase, Glucose
- All makers of Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
- All makers of Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated September 1, 2026. 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.