SD BIOSENSOR, INC.

Korea, Republic · Suwon-Si

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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

7listed device types

Class I 4Class II 2Class III 0unclassified 1

plus 8 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

15registered devices

Class I 5Class II 10

68 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

7 including historic records

TWTaiwanTFDA

17valid device licences

Class I 12Class II 3Class III 2

SGSingaporeHSA SMDR

16device registrations

CLASS B 3CLASS C 7CLASS D 6

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

IVD Class 1 4IVD Class 2 1IVD Class 3 6

HKHong KongMDACS

24valid listings

IVD B 7IVD C 15IVD D 2

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

17active registrations

Class 2a 2Class 2b 7Class 3 8

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 States8 registration records, 6 510(k), 0 PMA, 1 excluded

Brazil15 confirmed, 2 excluded

Manufacturer names merged into this page: SD BIOSENSOR, INC. · SD Biosensor, Inc. · SD BIOSENSOR, INC · SD BIOSENSOR INC. · SD BIOSENSOR · SD BIOSENSOR,INC.

FDA 510(k) clearances by year

12014 · K123517

32015 · K151265

12016 · K153201

12017 · K160282

FDA listed device types

Glucose Oxidase, Glucose 1System, Test, Blood Glucose, Over The Counter 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Ldl & Vldl Precipitation, Hdl 1Enzymatic Esterase--Oxidase, Cholesterol 1Colorimetric Method, Triglycerides 1Coronavirus Antigen Detection Test System. 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K160282	SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System	2017-10-17
US	K153201	SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System	2016-06-24
US	K151265	SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System	2015-11-24
BR	80954880241	STANDARD i Trigger	Class I
BR	80954880242	STANDARD i pre-Trigger	Class I
BR	80954880244	Família de analisadores Standard i	Class II

SD BIOSENSOR, INC.

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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