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: ASM-4, AVT-4F-8/900, AS-20, AS-10, A2B 32/40-1000.
Among these devices, 59 are declared sterile, 1 implantable.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 59 |
| Country of registration | Germany |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 005176 0009 | issued | 2031-07-06 |