Andramed GmbH
DE-MF-000005706 · Germany · Reutlingen
Andramed GmbH is registered in the European database on medical devices as a manufacturer, with 59 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 58 |
|---|---|
| Class I | 1 |
Most frequent device types declared: A2B 20/40-1000, A2B 22/40-1000, A2B 28/60-1000, A2B 32/40-1000, ABXL 16/40-1200.
Among these devices, 59 are declared sterile, 1 implantable.
Devices declared under this manufacturer
- Andra2Balloon
- AndraBalloon
- AndraSnare
- AndraSnare Micro
- AndraStent Arortic
- AndraValvulotome
Showing 12 of 59 declared devices.
Catalogue references include A2B 20/40-1000, A2B 28/60-1000, A2B 32/40-1000, ABXL 28/60-1200, AS-10, AS-20.
European nomenclature codes declared: C010402020102, V0501, C019017, P070402020102, C019005.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 59 |
| 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 | 59 |
|---|---|
| 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. Andramed GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 005176 0009 | issued | 2031-07-06 |