Advanced Medical Balloons GmbH
DE-MF-000008364 · Germany · Waghäusel
Advanced Medical Balloons GmbH is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 7 |
|---|
Most frequent device types declared: stool collection bag, stool drainage system.
Devices declared under this manufacturer
- hygh-tec bag
- hygh-tec basic plus
- hygh-tec basic-plus
- hygh-tec odor-solution
Catalogue references include V01-10016-05, V01-10016-10, V01-10017, V01-10023, V01-10027.
European nomenclature codes declared: A060399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ADVANCED MEDICAL BALLOONS GMBH (DE) · FDA 3015237508 |
| Devices in EUDAMED | 7 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| 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: United States only. Advanced Medical Balloons GmbH is registered in the United States but was not found in the Canadian register.