FDA Registration
Active
🇩🇪 Germany
PAUL HARTMANN AG
Reg #: 8010690
·
FEI: 2926
·
Expires 2026
Products
9
Proprietary Names
14
Establishment Types
5
Classifications
9
Registration Details
- Registration Name
- PAUL HARTMANN AG
- Registration Number
- 8010690
- FEI Number
- 2926
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Paul-Hartmann-Str. 12
- City
- Heidenheim An Der Brenz Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K242758
Owner / Operator
- Firm Name
- PAUL HARTMANN AG
- Operator Number
- 8010690
- Address
- 481 Lakeshore Parkway, --
- City
- Rock Hill
- State
- SC
- Postal Code
- 29730
- Country
- US
- Correspondent
- Lee Xiong
US Agent
- Business Name
- HARTMANN USA
- Contact Name
- Diane Marsilio
- Address
- 481 Lakeshore Parkway
- City
- Rock Hill
- State
- SC
- ZIP
- 29730
- Country
- US
- [email protected]
- Phone
- 803 9851120
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reminder, Medication | NXQ | Class 1 | Physical Medicine | No | 2025-07-17 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2024-06-25 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2007-04-02 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2006-11-15 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2005-07-27 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2006-11-15 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2006-11-15 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2026-03-05 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2025-01-09 |
Proprietary Names
Vintens Patient App
Dignity Super Multiple Styles
Moliform Multiple Styles
Dignity, Multiple Styles
Dignity Complete Multiple Styles
Dignity Extra Multiple Styles
Molimed Multiple Styles
Dignity Compose Multiple Styles
Molicare Multiple Styles
Cosmopor Transparent Steril
Hydrofilm
HydroTac
PERMAFOAM
Atrauman® Ag
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device
Foreign Private Label Distributor