Home›SD BIOSENSOR HEALTHCARE PVT. LTD

SD BIOSENSOR HEALTHCARE PVT. LTD

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, South Korea — 4 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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

IVD import 1IVD manufacturing 3

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 HEALTHCARE PVT. LTD

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies