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BK MEDICAL APS

Denmark · Herlev

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 0Class II 5Class III 0

plus 7 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class III 2

13 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS D 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

14active ARTG entries

Class I 3Class III 3IIa 5IIb 2Class Is (sterile) 1

HKHong KongMDACS

3valid listings

Class II 2Class III 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States7 registration records, 9 510(k), 0 PMA, 7 excluded

Brazil2 confirmed, 6 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: BK MEDICAL APS

FDA 510(k) clearances by year

32015 · K151910

12016 · K161960

22018 · K180737

12022 · K222441

22023 · K231764

FDA listed device types

Automated Radiological Image Processing Software 1Biopsy Needle 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Imaging, Pulsed Doppler, Ultrasonic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231764	Ultrasound System 1300	2023-10-23
US	K223830	Ultrasound System 2300	2023-04-11
US	K222441	Ultrasound System 2300	2022-12-07
BR	10302860235	EQUIPAMENTO DE ULTRASSOM BK MEDICAL	Class II
BR	10302869005	EQUIPAMENTO DE ULTRASSOM BKSPECTO	Class II
CA	65623	MERLIN ULTRASOUND SCANNER TYPE 1101 SYSTEM	Class III
CA	70586	PRO FOCUS 2202 ULTRASOUND SCANNER	Class III