BABGENCEL GmbH
DE-MF-000019691 · Germany · Düsseldorf
BABGENCEL GmbH is registered in the European database on medical devices as a manufacturer, with 578 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 578 |
|---|
Most frequent device types declared: 20HW01 / 20HW02, 20AW01 / 20AW02 / 20AW03, 21TW02 / 21TW03, 22BW01 / 22BW02, 20AS01 / 20AS01 / 20AS03.
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 | 578 |
| 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 |
|---|---|---|
MDR00145-A | issued | 2030-02-03 |