Ok Biotech Co L T D

FDA Filings

This page includes the latest FDA filings for Ok Biotech Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

TAIWAN

TAIWAN STOCK EXCHANGE

4155

DUNS 658796458

FDA Registration(s)

Registration Number

3005862821

FEI Number

3005862821

Name

OK BIOTECH CO., LTD.

Owner & Operator

OK BIOTECH CO., LTD.

Contact Address

No. 91, Sec. 2 Gongdao 5th Rd.
Hsinchu City TW-HSQ Hsinchu - District 30070 TW

US Agent

Esther Liu
JS US Representative Office
404 9323207
fda@jinservices.com

Importing Logistics Registration

Importer	1912 Walton
Address	1912 S Walton Blvd., Ste A Bentonville, AR 72712 UNITED STATES

Importing Logistics Registration

Importer	Cambridge Sensors USA, LLC
Address	10051 Bode Road Plainfield Illinois Plainfield, IL 60585 UNITED STATES

Importing Logistics Registration

Importer	Respitronics, LLC
Address	18948 Casual Cay Lane Cornelius, NC 28031 UNITED STATES

Importing Logistics Registration

Importer	UniStrip Technologies, LLC (NC)
Address	301 McCullough Drive, Suite 400 Charlotte, NC 28262 UNITED STATES
Importer Type	Agent

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

NO. 91, SEC. 2 Gongdao 5th Rd.
HSINCHU CITY Hsinchu - District, 30070 TW

Establishment Type

Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 04712803564141 OK BIOTECH CO., LTD.	Smartest Persona II Multi Blood Glucose Monitoring System	2023-08-31
GUDID 00852169003015 OK BIOTECH CO., LTD.	Perfect 3 Multi Blood Glucose Test Strips	2023-08-31
PMN K213061 OK BioTech Co., Ltd.	SuperCheck Pro Blood Glucose Monitoring System	2022-10-07
PMN K171785 \| NBW OK BIOTECH CO., LTD.	WowGoHealth	2019-06-27
PMN K141351 \| NBW OK BIOTECH CO., LTD.	SuperCheck Plus	2019-06-27
PMN K141351 \| NBW OK BIOTECH CO., LTD.	SuperCheck Plus Multi	2019-06-27
PMN K141351 \| LFR OK BIOTECH CO., LTD.	SuperCheck Plus	2019-06-27
PMN K141351 \| LFR OK BIOTECH CO., LTD.	SuperCheck Plus Multi	2019-06-27
PMN K141351 \| JJX OK BIOTECH CO., LTD.	SuperCheck Plus	2019-06-27
PMN K141351 \| JJX OK BIOTECH CO., LTD.	SuperCheck Plus Multi	2019-06-27
PMN K093764 \| NBW OK BIOTECH CO., LTD.	SOLO V2	2019-06-27
PMN K093764 \| CGA OK BIOTECH CO., LTD.	SOLO V2	2019-06-27
PMN K133509 \| NBW OK BIOTECH CO., LTD.	Smartest Persona II	2019-01-29
PMN K133509 \| NBW OK BIOTECH CO., LTD.	Smartest Persona II Multi	2019-01-29
PMN K133509 \| NBW OK BIOTECH CO., LTD.	Easy Plus II	2019-01-29
PMN K133509 \| NBW OK BIOTECH CO., LTD.	Easy Plus II Multi	2019-01-29
PMN K133509 \| JJX OK BIOTECH CO., LTD.	Smartest Persona II	2019-01-29
PMN K133509 \| JJX OK BIOTECH CO., LTD.	Smartest Persona II Multi	2019-01-29
PMN K133509 \| JJX OK BIOTECH CO., LTD.	Easy Plus II	2019-01-29
PMN K133509 \| JJX OK BIOTECH CO., LTD.	Easy Plus II Multi	2019-01-29
PMN K133509 \| CGA OK BIOTECH CO., LTD.	Smartest Persona II	2019-01-29
PMN K133509 \| CGA OK BIOTECH CO., LTD.	Smartest Persona II Multi	2019-01-29
PMN K133509 \| CGA OK BIOTECH CO., LTD.	Easy Plus II	2019-01-29
PMN K133509 \| CGA OK BIOTECH CO., LTD.	Easy Plus II Multi	2019-01-29
PMN K122525 \| NBW OK BIOTECH CO., LTD.	Smartest Glucowise	2019-01-29
PMN K122525 \| NBW OK BIOTECH CO., LTD.	Smartest Glucowise Multi	2019-01-29
PMN K122525 \| NBW OK BIOTECH CO., LTD.	Perfect 3 Multi	2019-01-29
PMN K122525 \| JJX OK BIOTECH CO., LTD.	Smartest Glucowise	2019-01-29
PMN K122525 \| JJX OK BIOTECH CO., LTD.	Smartest Glucowise Multi	2019-01-29
PMN K122525 \| JJX OK BIOTECH CO., LTD.	Perfect 3 Multi	2019-01-29
PMN K122525 \| CGA OK BIOTECH CO., LTD.	Smartest Glucowise	2019-01-29
PMN K122525 \| CGA OK BIOTECH CO., LTD.	Smartest Glucowise Multi	2019-01-29
PMN K122525 \| CGA OK BIOTECH CO., LTD.	Perfect 3 Multi	2019-01-29
PMN K100560 \| NBW OK BIOTECH CO., LTD.	Easy Talk	2019-01-29
PMN K100560 \| CGA OK BIOTECH CO., LTD.	Easy Talk	2019-01-29
PMN K091815 \| NBW OK BIOTECH CO., LTD.	Supercheck 1	2019-01-29
PMN K091815 \| NBW OK BIOTECH CO., LTD.	Perfect 3	2019-01-29
PMN K091815 \| NBW OK BIOTECH CO., LTD.	Oracle	2019-01-29
PMN K091815 \| CGA OK BIOTECH CO., LTD.	Supercheck 1	2019-01-29
PMN K091815 \| CGA OK BIOTECH CO., LTD.	Perfect 3	2019-01-29
PMN K091815 \| CGA OK BIOTECH CO., LTD.	Oracle	2019-01-29
GUDID 00193169642409 OK BIOTECH CO., LTD.	TruePoint 64240	2019-01-03
GUDID 00193169642362 OK BIOTECH CO., LTD.	TruePoint 64236	2019-01-03
GUDID 00193169642348 OK BIOTECH CO., LTD.	TruePoint 64234	2019-01-03
GUDID 00193169642331 OK BIOTECH CO., LTD.	TruePoint 64233	2019-01-03
GUDID 00193169642324 OK BIOTECH CO., LTD.	TruePoint 64232	2019-01-03
GUDID 10193169642307 OK BIOTECH CO., LTD.	TruePoint 64230	2018-10-29
PMN K162430 \| NBW OK BIOTECH CO., LTD.	TruePoint	2017-01-23
PMN K162430 \| NBW OK BIOTECH CO., LTD.	Equate	2017-01-23
PMN K162430 \| CGA OK BIOTECH CO., LTD.	TruePoint	2017-01-23
PMN K162430 \| CGA OK BIOTECH CO., LTD.	Equate	2017-01-23
PMN K162430 OK BIOTECH CO., LTD.	UniStrip1 Generic Blood Glucose Test Strips	2017-01-19
PMN K160038 OK BIOTECH CO., LTD.	UniStrip1 Generic Blood Glucose Test Strips	2016-07-29
PMN K152599 \| NBW OK BIOTECH CO., LTD.	Prodigy Astro	2016-07-25
PMN K152599 \| NBW OK BIOTECH CO., LTD.	Prodigy Astro Pro	2016-07-25
PMN K152599 \| CGA OK BIOTECH CO., LTD.	Prodigy Astro	2016-07-25
PMN K152599 \| CGA OK BIOTECH CO., LTD.	Prodigy Astro Pro	2016-07-25
PMN K152599 OK BIOTECH CO., LTD.	PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System	2016-07-20
PMN K142785 \| NBW OK BIOTECH CO., LTD.	Prodigy iConnect	2015-12-22
PMN K142785 \| CGA OK BIOTECH CO., LTD.	Prodigy iConnect	2015-12-22
PMN K141914 \| NBW OK BIOTECH CO., LTD.	Prodigy AutoCode	2015-12-22
PMN K141914 \| NBW OK BIOTECH CO., LTD.	Prodigy AutoCode Eject	2015-12-22
PMN K141914 \| CGA OK BIOTECH CO., LTD.	Prodigy AutoCode	2015-12-22
PMN K141914 \| CGA OK BIOTECH CO., LTD.	Prodigy AutoCode Eject	2015-12-22
PMN K142785 OK BIOTECH CO., LTD.	PRODIGY IConnect Blood Glucose Monitoring System	2015-12-17
PMN K141914 OK BIOTECH CO., LTD.	PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM	2015-04-15
PMN K132633 \| NBW OK BIOTECH CO., LTD.	OKmeter Direct	2014-09-26
PMN K132633 \| CGA OK BIOTECH CO., LTD.	OKmeter Direct	2014-09-26
PMN K132633 OK BIOTECH CO., LTD.	OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM	2014-08-14
PMN K122340 \| NBW OK BIOTECH CO., LTD.	Prodigy Choice	2013-12-13
PMN K122340 \| CGA OK BIOTECH CO., LTD.	Prodigy Choice	2013-12-13
PMN K122338 \| NBW OK BIOTECH CO., LTD.	Prodigy Preferred	2013-12-13
PMN K122338 \| CGA OK BIOTECH CO., LTD.	Prodigy Preferred	2013-12-13
PMN K060467 \| NBW OK BIOTECH CO., LTD.	Densu Check	2013-12-13
PMN K060467 \| JJX OK BIOTECH CO., LTD.	Densu Check	2013-12-13
PMN K060467 \| CGA OK BIOTECH CO., LTD.	Densu Check	2013-12-13
PMN K103115 \| NBW OK BIOTECH CO., LTD.	Prodigy	2013-01-18
PMN K103115 \| JQP OK BIOTECH CO., LTD.	Prodigy	2013-01-18
PMN K090307 \| CAF OK BIOTECH CO., LTD.	Respitronics Pocket Mist Portable nebulizer	2013-01-18
PMN K090307 \| CAF OK BIOTECH CO., LTD.	Prodigy Mini Mist	2013-01-18
PMN K073118 \| NBW OK BIOTECH CO., LTD.	Prodigy Voice	2012-01-19
PMN K073118 \| NBW OK BIOTECH CO., LTD.	Prodigy Pocket	2012-01-19
PMN K073118 \| NBW OK BIOTECH CO., LTD.	Prodigy No Coding	2012-01-19
PMN K073118 \| NBW OK BIOTECH CO., LTD.	Prodigy AutoCode	2012-01-19
PMN K073118 \| NBW OK BIOTECH CO., LTD.	Densu Check	2012-01-19
PMN K073118 \| NBW OK BIOTECH CO., LTD.	Densu Check Pocket	2012-01-19
PMN K073118 \| NBW OK BIOTECH CO., LTD.	Densu Check No Coding	2012-01-19
PMN K073118 \| CGA OK BIOTECH CO., LTD.	Prodigy Voice	2012-01-19
PMN K073118 \| CGA OK BIOTECH CO., LTD.	Prodigy Pocket	2012-01-19
PMN K073118 \| CGA OK BIOTECH CO., LTD.	Prodigy No Coding	2012-01-19
PMN K073118 \| CGA OK BIOTECH CO., LTD.	Prodigy AutoCode	2012-01-19
PMN K073118 \| CGA OK BIOTECH CO., LTD.	Densu Check	2012-01-19
PMN K073118 \| CGA OK BIOTECH CO., LTD.	Densu Check Pocket	2012-01-19
PMN K073118 \| CGA OK BIOTECH CO., LTD.	Densu Check No Coding	2012-01-19
PMN K090609 \| NBW OK BIOTECH CO., LTD.	Prodigy Voice	2010-03-21
PMN K090609 \| NBW OK BIOTECH CO., LTD.	OKmeter Match	2010-03-21
PMN K090609 \| JJX OK BIOTECH CO., LTD.	Prodigy Voice	2010-03-21
PMN K090609 \| JJX OK BIOTECH CO., LTD.	OKmeter Match	2010-03-21
PMN K090609 \| CGA OK BIOTECH CO., LTD.	Prodigy Voice	2010-03-21
PMN K090609 \| CGA OK BIOTECH CO., LTD.	OKmeter Match	2010-03-21
PMN K090609 OK BIOTECH CO., LTD.	OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM	2010-02-04
PMN K063026 \| NBW OK BIOTECH CO., LTD.	OK METER	2007-03-29
PMN K063026 \| JJX OK BIOTECH CO., LTD.	OK METER	2007-03-29
PMN K063026 \| CGA OK BIOTECH CO., LTD.	OK METER	2007-03-29
PMN K063026 OK BIOTECH CO., LTD.	OK METER BLOOD GLUCOSE MONITORING SYSTEM	2007-02-09
FMK OK BIOTECH CO., LTD.	Prodigy Adjustable Depth Lancing Device	2006-08-09

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009195185	Kaohsiung,China (Taiwan) -> Charleston, South Carolina	2697CTNS = 22PALLETS PRODIGY NO CODING BLO OD GLUCOSE TEST STRIP PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM PRODIGY POCKET BL OOD GLUCOSE MONITORING SYSTEM PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM	2697 CTN
202008284369	Kaohsiung,China (Taiwan) -> Charleston, South Carolina	2240CTNS = 19PALLETS PRODIGY NO CODING BLOOD GLUCOSE TEST STRIP PORDIGY AUTOCODE BLOOD GL UCOSE MONITORING SYSTEM	2240 CTN
202008195168	Kaohsiung,China (Taiwan) -> Charleston, South Carolina	824CTNS = 17PALLETS PRODIGY NO CODING BLOOD GLUCOSE TEST STRIP	824 CTN
2020072114188	Panama Canal - Caribbean,Panama -> Charleston, South Carolina	4152CTNS = 22PALLETS PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM PRODIGY NO CODING B LOOD GLUCOSE TEST STRIP 50CT WALMART BRANDED EQUATE TEST STRIP	4152 CTN
202007033031	Pusan,South Korea -> Miami, Florida	EASYTALK METER HIGH/LOW CONTROL SOLUTION (67C .	67 CTN
2020061961051	Puerto Manzanillo,Panama -> Miami, Florida	OMAX BLOOD GLUCOSE METER KIT OMAX BLOOD GLUCOSE TEST STRIP WITH BOX OMAX BLOOD GLUCOSE TEST STRIP VIAL	40 PKG
202005255234	Pusan,South Korea -> Charleston, South Carolina	3590CTNS = 22PALLETS PRODIGY NO CODING BLOOD GLUCOSE TEST STRIP PRODIGY POCKET BLOOD GLUC OSE MONITORING SYSTEM PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM 50CT WALMART BRANDE D EQUATE TEST STRIP	3590 CTN
202005231168	Kaohsiung,China (Taiwan) -> Charleston, South Carolina	1218CTNS = 22PALLETS PRODIGY NO CODING BLOOD GLUCOSE TEST STRIP	1218 CTN