Data / Medical devices / Germany / Paul Hartmann AG
Paul Hartmann AG: FDA-registered device maker in Heidenheim An Der Brenz Baden-Wurttemberg, Germany, 1 510(k) clearance
Paul Hartmann AG is registered with the FDA (registration 8010690) in Heidenheim An Der Brenz Baden-Wurttemberg, Germany. It lists 9 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
- 8010690
- FEI number
- 2926
- Address
- Paul-Hartmann-Str. 12, Heidenheim An Der Brenz Baden-Wurttemberg, Germany, 89522
- Owner or operator
- PAUL HARTMANN AG (8010690)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer, Specification developer
- First device listed
- July 27, 2005
- Registered through
- 2026
- Brand names listed
- Atrauman® Ag, Cosmopor Transparent Steril, Dignity Complete Multiple Styles, Dignity Compose Multiple Styles, Dignity Extra Multiple Styles, Dignity Super Multiple Styles, Dignity, Multiple Styles, HydroTac and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Manufacturer | accessdata.fda.gov |
| Reminder, Medication | NXQ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US | 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 Protector, Skin Pressure
- All makers of Garment, Protective, For Incontinence
- All makers of Dressing, Wound, Drug
- All makers of Bandage, Elastic
- All makers of Dressing, Wound, Occlusive
- All makers of Dressing, Wound, Hydrophilic
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.