PAUL HARTMANN AG
DE-MF-000005861 · Germany · Heidenheim
PAUL HARTMANN AG is registered in the European database on medical devices as a manufacturer, with 288 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 280 |
|---|---|
| Class IIb | 8 |
Most frequent device types declared: 1275, 1439, 1472, 2502, 3105.
Among these devices, 70 are declared sterile.
Devices declared under this manufacturer
- Confiance MEN
- Confiance Mobile
- Confiance Secure
- Cosmopor Advance
- Cosmopor E Steril
- DermaPlast textil
- HARTMANN Comfort
- HARTMANN Protect
- HARTMANN Protect Plus extra reinforced
- HydroClean Mini
- NURSA Slip
- Omnistrip
Showing 12 of 288 declared devices.
Catalogue references include 166066, 242946, 300004, 432370, 522410, 540010.
European nomenclature codes declared: T0399, M04010199, T04010103, T04010102, M040499, M0303010101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PAUL HARTMANN AG (DE) · FDA 8010690 |
| Devices in EUDAMED | 288 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 288 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 0.3 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. PAUL HARTMANN AG is registered in the United States but was not found in the Canadian register.