Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBk Medical ApS
US
Last updated May 24, 2026
What Bk Medical ApS makes
Bk Medical ApS manufactures ultrasound imaging transducers, including extended single-use biopsy guides, rectal/vaginal probes, and reusable needle guides for surgical and diagnostic procedures. Their portfolio also includes hand-held extracorporeal ultrasound transducers, intracorporeal contouring attachments, and general-purpose ultrasound systems like the Flex Focus. Additional products cover remote controls for diagnostic radiography devices and specialized transducers such as curved arrays and biplane intraoperative models.
The company’s devices are classified as Class II under FDA regulations and are listed in the 510(k) and UDI registries. Their products are designed and distributed from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Bk Medical ApS manufacture?
Bk Medical ApS specializes in ultrasound-related devices, including surgical and extracorporeal ultrasound imaging transducers, such as the 6C2 and Curved Array models. Their portfolio also covers single-use and reusable needle guides for procedures, rectal/vaginal ultrasound probes, and specialized attachments like the Intraoperative Biplane Transducer. Additionally, they produce general-purpose ultrasound systems, such as the Flex Focus, and remote controls for diagnostic radiography devices. These products are designed for imaging, guidance, and procedural support in clinical settings.
Where is Bk Medical ApS based, and where are its devices manufactured or distributed?
Bk Medical ApS is based in the United States. While the provided data does not specify manufacturing locations, the company’s devices are designed and distributed from the U.S., ensuring compliance with regulatory standards applicable to American markets.
Which regulatory registries list Bk Medical ApS’s devices?
Bk Medical ApS’s devices are listed in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) database. These registries track Class II devices to ensure compliance with U.S. regulatory requirements for medical device safety and performance.
How are Bk Medical ApS’s devices classified under FDA regulations?
All of Bk Medical ApS’s listed devices fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as ultrasound transducers, needle guides, and imaging systems. Class II devices undergo regulatory oversight, including 510(k) clearance, to demonstrate substantial equivalence to existing approved devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- bkmedical.com
- —
- —
- [email protected]
- Phone
- +4544528100
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 310093901
Catalogue (123)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mobile Touch Dock with battery | UA1814 | FDA UDI | Class II | Unknown |
| E14C4t Transducer | 9018 | FDA UDI | Class II | Active |
| Mobile Keyboard Dock | UA1210 | FDA UDI | Class II | Unknown |
| 14L3e Transducer | 9086 | FDA UDI | Class II | Active |
| Wireless Remote Control | UA2361 | FDA UDI | Class II | Active |
| Burr-Hole Transducer | 8863 | FDA UDI | Class II | Active |
| Linear Array Transducer | 8811 | FDA UDI | Class II | Active |
| Dummy Channel Bracket | UA1325 | FDA UDI | Class II | Active |
| Rectosigmoidoscope with Obturator | UA0672 | FDA UDI | Class II | Active |
| E14CL4b Transducer | 9048 | FDA UDI | Class II | Active |
| Mobile Keyboard Dock with battery | UA1214 | FDA UDI | Class II | Unknown |
| 5P1e Transducer | 9087 | FDA UDI | Class II | Active |
| E11C3b Transducer | 9008 | FDA UDI | Class II | Active |
| I14C5T Transducer | 9016 | FDA UDI | Class II | Active |
| Single-Use Needle Guide | UA1336 | FDA UDI | Class II | Active |
| Mobile Touch Dock | UA1810 | FDA UDI | Class II | Unknown |
| I12C5b Transducer | 9024 | FDA UDI | Class II | Active |
| Non-implantable, needle guide, reusable | UA1327 | FDA UDI | Class II | Active |
| Foot Switch | UA2352 | FDA UDI | Class II | Active |
| Single-Use Needle Guide | UA1337 | FDA UDI | Class II | Active |
| Single-Use Biopsy guide | UA1257-S14 | FDA UDI | Class II | Active |
| E14C4 Transducer | 9067 | FDA UDI | Class II | Unknown |
| Single Use Needle Guide | UA1339 | FDA UDI | Class II | Active |
| 18L5 Transducer | 9070 | FDA UDI | Class II | Active |
| Non-implantable, needle guide, reusable | UA1349 | FDA UDI | Class II | Active |
| Curved Array Transducer | 8823 | FDA UDI | Class II | Active |
| Linear Array Transducer | 8670 | FDA UDI | Class II | Active |
| Single-Use Dual Biopsy Guide | UA1329-S | FDA UDI | Class II | Active |
| I14C5I Transducer | 9015 | FDA UDI | Class II | Active |
| N13C5 Transducer | 9062 | FDA UDI | Class II | Active |
| Curved Array Transducer | 8830 | FDA UDI | Class II | Active |
| Non-implantable, needle guide, reusable | UA1328 | FDA UDI | Class II | Active |
| bk3000, bk3500, bk5000, bkActiv | 2300 | FDA UDI | Class II | Active |
| 20R3 Transducer | 9052 | FDA UDI | Class II | Active |
| bkSpecto Ultrasound System | 1300 | FDA UDI | Class II | Active |
| Endfire Curved Array Transducer | 8667 | FDA UDI | Class II | Active |
| Single-Use Needle Guide | UA1345 | EUDAMEDFDA UDI | Class II | Active |
| Rob12C4 | 9096 | FDA UDI | Class II | Active |
| X18L5s Transducer | 9009 | FDA UDI | Class II | Active |
| Endovaginal Transducer | 8819 | FDA UDI | Class II | Active |
| Vascular Transducer | 8822 | FDA UDI | Class II | Active |
| Small Footprint Cardiac Transducer | 8837 | FDA UDI | Class II | Unknown |
| Keyboard Table Dock | UA1283 | FDA UDI | Class II | Unknown |
| Single-Use Biplane Biopsy Guide | UA1322-S | FDA UDI | Class II | Active |
| “Hockey Stick” Transducer | 8809 | FDA UDI | Class II | Active |
| Water Standoff Collar | UA0671 | FDA UDI | Class II | Active |
| Non-implantable, needle guide, reusable | UA1324 | FDA UDI | Class II | Active |
| N20P6 Transducer | 9007 | FDA UDI | Class II | Active |
| Disposable Needle Guide | UA1344 | FDA UDI | Class II | Active |
| Intraoperative Transducer | 8815 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Bk Medical Aps HERLEV Hovedstaden · DK FEI 3003705156