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OK BIOTECH CO., LTD.

Taiwan · Hsinchu City

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Russia — 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 3Class II 7Class III 0

plus 26 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class I 5Class II 6

32 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

5active registrations

Class 2a 1Class 2b 4

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 States26 registration records, 9 510(k), 0 PMA, 2 excluded

Brazil11 confirmed, 1 excluded

Manufacturer names merged into this page: OK BIOTECH CO., LTD.

FDA 510(k) clearances by year

12007

12010

12014

22015

22016

12017

12022

FDA listed device types

showing 8 of 10

Glucose Oxidase, Glucose 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter 1Nebulizer (Direct Patient Interface) 1Syringe, Piston 1System, Test, Blood Glucose, Over The Counter 1Glucose Dehydrogenase, Glucose 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213061	SuperCheck Pro Blood Glucose Monitoring System	2022-10-07
US	K162430	UniStrip1 Generic Blood Glucose Test Strips	2017-01-19
US	K160038	UniStrip1 Generic Blood Glucose Test Strips	2016-07-29
BR	82765289003	Agulha Descartável para Caneta de Insulina OK BIOTECH	Class II
BR	80867150187	FAMÍLIA EXTRATOR DE PLASMA DE SANGUE BIOBASE	Class I
BR	80867150188	FAMÍLIA CZK HEMOSCALE (HOMOGENEIZADORA PARA BOLSAS DE SANGUE)	Class I

OK BIOTECH CO., LTD.

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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