Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

Bk Medical ApS

US

Last updated May 24, 2026

Information

Country
US
Address
—
Website
bkmedical.com
LinkedIn
—
Facebook
—
Phone
+4544528100
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
310093901

Catalogue (123)

Page 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
6C2s Transducer 9023
FDA UDI
Class IIActive
I13C3fx Transducer 9078
FDA UDI
Class IIActive
T-Shaped Intraoperative Transducer 8816
FDA UDI
Class IIActive
Ultrasound Scanner Pro Focus 2202 K132346
FDA 510(k)
Class IIActive
Ultrasound Scanner System BK2300 K151910
FDA 510(k)
Class IIActive
Needle Guide For 8814, Model Ua1335, Needle Guide For 8815, Model Ua 1336, Needle Guide For 8824, Model Ua 1337 K083667
FDA 510(k)
Class IIActive
Ultrasound Scanner Pro Focus 2202 K132685
FDA 510(k)
Class IIActive
Ultrasound Scanner System bk2300 K180737
FDA 510(k)
Class IIActive
Ultrasound System 2300 K222441
FDA 510(k)
Class IIActive
Ultrasound System 1300 K173569
FDA 510(k)
Class IIActive
bk2300 K161960
FDA 510(k)
Class IIActive
Ultrasound Scanner System bk2300 K143298
FDA 510(k)
Class IIActive
Ultrasound Scanner Profocus, Model 2202 K070077
FDA 510(k)
Class IIActive
Biopsy Guide Kit For 8808 And Biplane, Endfire And Dual Biopsy Guides For 8818 K081323
FDA 510(k)
Class IIActive
Ultrasound Scanner System bk2300 K152052
FDA 510(k)
Class IIActive
Ultrasound Scanner Flex Focus 1202 K132677
FDA 510(k)
Class IIActive
Pro Focus 2202, Pro Focus 2202 Uv Model: Type 2202 K100919
FDA 510(k)
Class IIActive
Ultrasound Scanner Flex Focus K123254
FDA 510(k)
Class IIActive
Ultrasound System 2300 K223830
FDA 510(k)
Class IIActive
Ultrasound Scanner Flex Focus, Model 1202 K081154
FDA 510(k)
Class IIActive
Ultrasound Scanner System Bk2300 K140428
FDA 510(k)
Class IIActive
Ultrasound Scanner Flex Focus 1202 K132335
FDA 510(k)
Class IIActive
Ultrasound System 1300 K231764
FDA 510(k)
Class IIActive

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