BK Medical ApS
DK-MF-000006447 · Denmark · Herlev
BK Medical ApS is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 8 |
|---|---|
| Class IIb | 1 |
Among these devices, 1 are declared sterile, 1 active.
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 | BK MEDICAL APS (DK) · FDA 9680269 |
| Devices in EUDAMED | 9 |
| Country of registration | Denmark |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
10000449961-PA-NoMA-DNK | issued | 2027-07-17 |