Data / Medical devices / Poland / PAUL HARTMANN Manufacturing Sp. z o.o.
PAUL HARTMANN Manufacturing Sp. z o.o.: FDA-registered device maker in Libidza Dolnoslaskie, Poland, 1 510(k) clearance
PAUL HARTMANN Manufacturing Sp. z o.o. is registered with the FDA (registration 3029971427) in Libidza Dolnoslaskie, Poland. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 9, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029971427
- Address
- Wspolna 3, Libidza Dolnoslaskie, Poland, 42-125
- Owner or operator
- PAUL HARTMANN AG (8010690)
- Roles
- Manufacturer
- First device listed
- November 15, 2006
- Registered through
- 2026
- Brand names listed
- Atrauman® Ag, Cosmopor Transparent Steril, HydroTac, Hydrofilm, PERMAFOAM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 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 |
|---|---|---|---|---|---|---|
| December 9, 2024 | K242758 | Atrauman® Ag | FRO | Substantially Equivalent | Hartmann USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tape And Bandage, Adhesive
- All makers of Dressing, Wound, Occlusive
- All makers of Dressing, Wound, Drug
Updated December 9, 2024. 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.