Bistos Co L T D

FDA Filings

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

FDA Registration(s)

Registration Number

3006179052

FEI Number

3006179052

Name

Daniel Lim

Owner & Operator

Bistos Co., Ltd.

Contact Address

7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302 Galmachi-ro, Jungwon-gu,
Seongnam KR-41 Gyeonggido 13201 KR

US Agent

Daniel Lim
Bistos America
949 6148745
949 6148745
daniellim@bistosamericainc.com

Importing Logistics Registration

Importer	MOTIF MEDICAL, LLC
	80516147
Address	8 THE GRN STE 5601 Dover, DE 19901 UNITED STATES
Email Address	Jon.Abbotts@aeroflowinc.com
Phone	1 844 2728390
Importer Type	RETAILER

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

22941 Triton Way, Suite 242
Laguna Hills, CA 92653 US

Establishment Type

Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00887529000465 Bistos Co., Ltd.	Duo Double Electric Breast Pump	2021-11-05
GUDID 18800012345019 Bistos Co., Ltd.	BiliTouchTM	2021-06-17
GUDID 18800012345002 Bistos Co., Ltd.	Infant Phototherapy Equipment	2021-06-16
GUDID 18800012315036 Bistos Co., Ltd.	Hi bebe super	2021-06-16
GUDID 18800012315029 Bistos Co., Ltd.	Hi bebe super	2021-06-16
GUDID 18800012341011 Bistos Co., Ltd.	N/A CTD-HL-001	2021-06-15
GUDID 08800012341007 Bistos Co., Ltd.	N/A CTD-HL-001	2021-06-15
PMN K210289 Bistos Co., Ltd.	Infant Phototherapy Equipment	2021-05-28
PMN K200675 Bistos Co., Ltd.	Hi Bebe Super (Models BT-150S And BT-150L)	2021-02-10
GUDID 00887529000373 Bistos Co., Ltd.	N/A CTD-HL-001	2019-02-07
GUDID 00887529000366 Bistos Co., Ltd.	N/A CTD-HL-001	2019-02-07
GUDID 30887529000091 Bistos Co., Ltd.	N/A OSD-14220-001	2018-07-06
GUDID 30887529000084 Bistos Co., Ltd.	N/A OSD-14220-001	2018-07-06
GUDID 30887529000046 Bistos Co., Ltd.	N/A MKT-200-1501	2018-07-06
GUDID 30887529000039 Bistos Co., Ltd.	Hi-bebe MKT-200-1501	2018-07-06
GUDID 30887529000022 Bistos Co., Ltd.	Hi-bebe MKT-200-1501	2018-07-06
GUDID 30887529000015 Bistos Co., Ltd.	Hi-dop OSD-14200V-001	2018-07-06
GUDID 10887529000189 Bistos Co., Ltd.	N/A	2018-07-06
GUDID 10887529000165 Bistos Co., Ltd.	Hi bebe plus MKT-100-1509	2018-07-06
GUDID 10887529000134 Bistos Co., Ltd.	N/A MKT-500-1509	2018-07-06
GUDID 10887529000110 Bistos Co., Ltd.	N/A MKT-400-1510	2018-07-06
GUDID 10887529000103 Bistos Co., Ltd.	N/A OSD-15300-001	2018-07-06
GUDID 10887529000066 Bistos Co., Ltd.	N/A MKT-350-1509	2018-07-06
GUDID 10887529000059 Bistos Co., Ltd.	N/A MKT-350-1509	2018-07-06
GUDID 00887529000199 Bistos Co., Ltd.	Hi-bebe	2018-07-06
GUDID 00887529000151 Bistos Co., Ltd.	Duo Double Electric Breast Pump	2018-07-06
PMN K160274 \| HGX Daniel Lim [Bistos Co., Ltd.]	Hi bebe plus, BT-100	2016-09-07
PMN K160274 \| HGX Daniel Lim [Bistos Co., Ltd.]	Duo Double Electric Breast Pump, MD-20.2	2016-09-07
PMN K160274 BISTOS CO., LTD.	Hi Bebe Plus	2016-09-01
PMN K142799 \| HGM Daniel Lim [Bistos Co., Ltd.]	BT-220L Prenatal monitoring system	2015-07-13
PMN K142799 \| HGM Daniel Lim [Bistos Co., Ltd.]	BT-220C Prenatal monitoring system	2015-07-13
PMN K142799 Bistos Co., Ltd.	Model BT-220L And BT-220C	2015-07-09
PMN K142332 \| LBI Daniel Lim [Bistos Co., Ltd.]	BT-400 Neonatal Phototherapy	2015-03-25
PMN K132543 \| FMZ Daniel Lim [Bistos Co., Ltd.]	BT-500 Infant Incubator	2014-08-05
PMN K132543 BISTOS CO., LTD.	INFANT INCUBATOR	2014-07-03
PMN K121267 \| HGM Daniel Lim [Bistos Co., Ltd.]	BT-200 Vascular Doppler	2012-08-23
PMN K121267 BISTOS CO., LTD.	BT-200V VASCULAR DOPPLER	2012-08-02
HPP Daniel Lim [Bistos Co., Ltd.]	Head-worn light BT-410	2011-06-14
PMN K103545 \| HGM Daniel Lim [Bistos Co., Ltd.]	BT-350	2011-05-19
PMN K103545 \| HGL Daniel Lim [Bistos Co., Ltd.]	BT-350	2011-05-19
PMN K103545 BISTOS CO., LTD.	BT-350	2011-05-13
PMN K100885 \| HGM Daniel Lim [Bistos Co., Ltd.]	Hi-bebe	2010-06-16
PMN K100885 \| HGM Daniel Lim [Bistos Co., Ltd.]	Fetal Doppler	2010-06-16
PMN K100885 \| HGM Daniel Lim [Bistos Co., Ltd.]	Bistos Co., Ltd.	2010-06-16
PMN K100885 \| HGM Daniel Lim [Bistos Co., Ltd.]	BT-200T	2010-06-16
PMN K100885 BISTOS CO., LTD.	FETAL MONITOR MODEL: BT-200T	2010-06-07
PMN K052190 \| HGM Daniel Lim [Bistos Co., Ltd.]	BT-300	2007-11-22
PMN K052190 \| HGM Daniel Lim [Bistos Co., Ltd.]	BT-200 Hi Bebe Fetal Doppler	2007-11-22
PMN K052190 \| HGL Daniel Lim [Bistos Co., Ltd.]	BT-300	2007-11-22
PMN K052190 \| HGL Daniel Lim [Bistos Co., Ltd.]	BT-200 Hi Bebe Fetal Doppler	2007-11-22
PMN K052190 BISTOS CO., LTD.	FETAL MONITOR, MODELS BT-300 AND BT-200	2005-10-04

Related Finance Registrations

NCAGE Code	2G68F	BISTOS CO.,LTD
CAGE Code	2G68F	BISTOS CO.,LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020080318868	Pusan,South Korea -> Charleston, South Carolina	BREAST PUMP	30 PKG
2020080318868	Pusan,South Korea -> Charleston, South Carolina	BREAST PUMP	30 PKG
2020061370535	Pusan,South Korea -> Los Angeles, California	PATIENT MONITOR	47 PKG
202005308013	Pusan,South Korea -> Charleston, South Carolina	BREAST PUMP	30 PKG
202005308013	Pusan,South Korea -> Charleston, South Carolina	BREAST PUMP	30 PKG
2020051661404	Pusan,South Korea -> Long Beach, California	MEDICAL APPARATUS 9018.19	30 CTN
202003167882	Pusan,South Korea -> Charleston, South Carolina	BREAST PUMP	30 PKG
202003167882	Pusan,South Korea -> Charleston, South Carolina	BREAST PUMP	30 PKG
2020031339322	Pusan,South Korea -> Long Beach, California	MEDICAL APPARATUS 9018.19	1 PKG
2020022537983	Pusan,South Korea -> Long Beach, California	MEDICAL APPARATUS 9018.19	1 PKG
202002036075	Pusan,South Korea -> Charleston, South Carolina	BREAST PUMP	20 PKG