BD KIESTRA, B.V.

Netherlands · Drachten Fryslan

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 8 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

9listed device types

Class I 6Class II 3Class III 0

plus 9 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 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

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 1 2IVD Class 2 1

HKHong KongMDACS

2valid listings

IVD B 2

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 States9 registration records, 1 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: BD Kiestra B.V. · BD KIESTRA, B.V.

FDA 510(k) clearances by year

12023 · K213280

FDA listed device types

showing 8 of 9

Automated Colony Counter 1Device, General Purpose, Microbiology, Diagnostic 1Calculator/Data Processing Module, For Clinical Use 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Device, Microtiter Diluting/Dispensing 1Bath, Incubators/Water, All 1Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms 1Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213280	BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App	2023-05-04
BR	10033430838	BD Kiestra ReadA	Class I
BR	10033430845	BD Kiestra InoqulA	Class I

BD KIESTRA, B.V.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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