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 IIb | 1 |
|---|---|
| Class IIa | 8 |
Among these devices, 1 are declared sterile, 1 active.
Devices declared under this manufacturer
- 5P1e Transducer
Catalogue references include 9087, UA0671, UA0672, UA0673, UA1232, UA1239.
European nomenclature codes declared: A018002, Z11049099, Z110402010301.
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 |
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| Found in the U.S. device database | 9 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BK MEDICAL APS |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 3 devices | 5 |
| Class 4 devices | 1 |
| First licensed | 2009-04-16 |
Licence types: System (5), Device Group Family (1), Device Family (1).
Licensed under: BIOPSY AND NEEDLE GUIDES, ULTRASOUND SCANNER FLEX FOCUS 1202, ULTRASOUND TRANSDUCERS, BK3000/3500 ULTRASOUND SCANNER SYSTEM, BK5000 ULTRASOUND SYSTEM, ULTRASOUND SYSTEM 1300.
North American profile: Both markets. BK Medical ApS is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
10000449961-PA-NoMA-DNK | issued | 2027-07-17 |