Coloplast A/S
DK-MF-000025526 · Denmark · Humlebaek
Coloplast A/S is registered in the European database on medical devices as a manufacturer, with 11 480 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 11 412 |
|---|---|
| Class IIb | 68 |
Among these devices, 697 are declared sterile.
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 | Registered with FDA |
|---|---|
| Matched entry | COLOPLAST A/S (DK) · FDA 9610694 |
| Devices in EUDAMED | 11 480 |
| Country of registration | Denmark |