Dr. Ausbüttel GmbH & Co. KG
DE-MF-000005465 · Germany · Dortmund
Dr. Ausbüttel GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 30 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 30 |
|---|
Among these devices, 30 are declared sterile.
Devices declared under this manufacturer
- DracoFoam Infekt Pro 10x10 cm, 10 Stück
- DracoFoam Infekt Pro 18x18 cm, Muster 2 Stück
- DracoFoam Infekt Pro 5x5 cm, 10 Stück
- DracoFoam Infekt Pro haft 10x10 cm, 10 Stück
- DracoFoam Infekt Pro haft 5x5 cm, 10 Stück
- DracoFoam Infekt Pro haft 7,5x7,5 cm, Muster 3 Stück
- DracoFoam Infekt Pro haft sensitiv 10x10 cm, Muster 3 Stück
- DracoFoam Infekt Pro haft sensitiv 7,5x7,5 cm, Muster 3 Stück
- DracoFoam haft sensitiv, 5 cm x 5 cm
- DracoFoam haft, 12 cm x 22 cm
- DracoFoam haft, 17 cm x 17 cm
- DracoFoam haft, 5 cm x 5 cm
Showing 12 of 30 declared devices.
Catalogue references include 100208, 100209, 13912, 13928, 14012, 14018.
European nomenclature codes declared: M04040601, M040499.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 30 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 30 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: Neither register. Dr. Ausbüttel GmbH & Co. KG was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1487GB448260220 | issued | 2027-06-22 |