Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680269

FEI Number

3003705156

Entity Name

BK MEDICAL APS

City/State/Country

HERLEV Hovedstaden, DK

Establishment Address

MILEPARKEN 34, HERLEV Hovedstaden DK-2730, DK

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GE HealthCare Technologies Inc. (Owner Number: 9912004)

Owner / Operator Contact Address

3000 N. Grandview Blvd, Waukesha, WI 53188, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132335

PMA Number

N/A

All Registered Proprietary Names

UA1329-S (Sterile) UA1339 (Sterile) UA1257-S14 (Sterile) UA1323-S (Sterile) UA1322-S (Sterile) UA1257S17E (Sterile) UA1322-S14 (Sterile) 9015 (I14C5I) UA0673 (Rectosigmoidoscope) 9040 (6C2) 9070 (18L5) UA0672 (Rectosigmoidoscope) 9096 (Rob12C4) 9002 (9C2) 9052 (20R3) UA0671 (Water Standoff) UA1232 UA2379 Integrated TR Fusion Kit 2300 9066 (I12C4f) 9019 (E10C4) 9026 (X12C4) UA1325 (Channel Bracket) 9062 (N13C5) 9024 (I12C5b) 9016 (I14C5T) UA1282 UA1324 9018 (E14C4t) UA1349 9048 (E14CL4b) 9034 (I12C5) 2300 (bk3000, bk3500, bk5000, bkActiv) UA1251 9063 (N11C5s) UA1326 UA2390 Integrated TP Fusion Kit 2300 9085 (5C1e) 9078 (l13C3fx) 9023 (6C2s) 9051 (14L3) UA1328 9081 (18L5s) 9032 (8L2) 9009 (X18L5s) 9038 (X14L4) 9007 (N20P6) 9077 (5P1) UA1250 UA1325w (Channel Bracket) UA1327 UA1239 9076 (I13C3f) 9011 (13L4w) 9029 (E13C2) bkActiv S Series UA1345 (Sterile) UA1338 (Sterile) UA1346 (Sterile) UA1337 (Sterile) UA1336 (Sterile) UA1344 (Sterile) E14CL4b 14L3e 13L4w Ultrasound System 1300 I14C5T 18L5 8L2 5P1e 6C2s E11C3b 5C1e 20R3 X12C4 X14L4 I14C5I X18L5s 6C2 I12C5b 18L5s 14L3 E14C4t N11C5s 9c2 N13C5 E10C4 E13C2 8820e UA1328 UA1324 UA1326 UA1250 8848 8823 8838 8816 8819 8824 UA1251 8863 8826 8870 UA1232 UA1282 8667 8862 8808e 2052 8670 UA1239 8818 8811 UA1256 8666-RF 8809 1202 (Flex Focus) UA1327 8815

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2025-12-04
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-10-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-10-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-10-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-12-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-11-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-11-08
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2023-11-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-11-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-10-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-10-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-10-06

Official Correspondent

No official correspondent registered.

US Agent Details

Tracey Holevas Business: GE HealthCare Technologies, Inc Email: tracey.holevas@gehealthcare.com Phone: (262) 3092157

Related Public Records

Same Entity

GE HealthCare Technologies Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3015060224	IMACTIS, SAS	SAINT MARTIN D'HERES, FR
2122726	GE MEDICAL SYSTEMS, LLC	Milwaukee, WI, US
9617766	GE BE PRIVATE LIMITED	WHITEFIELD, BANGALORE Karnataka, IN
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04
K162372	Qt Ultrasound, LLC	QT Ultrasound Breast Scanner-1	2017-06-06
K930964	Acuson Corp.	ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)	1994-10-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2012	Olympus America Inc.	2	OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.

Similar Registrations

Registration Number	Establishment Name	Location
3042940295	NEONAVIA AB	Vallentuna Stockholm, SE
3016678045	Schneider ASR B.V.	Rotterdam-Albrandswaard Zuid-Holland, NL
3005099803	BOSTON SCIENTIFIC CORPORATION	Marlborough, MA, US
1828132	BOSTON SCIENTIFIC CORPORATION	SPENCER, IN, US
3010188783	JAPAN GAS COMPANY LIMITED	YOKOHAMA Kanagawa, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680269. Last updated year: 2026. Please use registration number 9680269 when referencing this establishment in official correspondence.