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 Number3006179052
FEI Number3006179052
NameDaniel Lim
Owner & OperatorBistos Co., Ltd.
Contact Address7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302 Galmachi-ro, Jungwon-gu,
Seongnam KR-41 Gyeonggido 13201 KR
US Agent
Importing Logistics Registration
ImporterMOTIF MEDICAL, LLC
80516147
Address8 THE GRN STE 5601
Dover, DE 19901 UNITED STATES
Email AddressJon.Abbotts@aeroflowinc.com
Phone1 844 2728390
Importer TypeRETAILER
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address22941 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
DeviceDate
Bistos Co., Ltd.
Hi Bebe Super (Models BT-150S And BT-150L)2021-02-10
Bistos Co., Ltd.
N/A CTD-HL-0012019-02-07
Bistos Co., Ltd.
N/A CTD-HL-0012019-02-07
Bistos Co., Ltd.
N/A OSD-14220-0012018-07-06
Bistos Co., Ltd.
N/A OSD-14220-0012018-07-06
Bistos Co., Ltd.
N/A MKT-200-15012018-07-06
Bistos Co., Ltd.
Hi-bebe MKT-200-15012018-07-06
Bistos Co., Ltd.
Hi-bebe MKT-200-15012018-07-06
Bistos Co., Ltd.
Hi-dop OSD-14200V-0012018-07-06
Bistos Co., Ltd.
N/A 2018-07-06
Bistos Co., Ltd.
Hi bebe plus MKT-100-15092018-07-06
Bistos Co., Ltd.
N/A MKT-500-15092018-07-06
Bistos Co., Ltd.
N/A MKT-400-15102018-07-06
Bistos Co., Ltd.
N/A OSD-15300-0012018-07-06
Bistos Co., Ltd.
N/A MKT-350-15092018-07-06
Bistos Co., Ltd.
N/A MKT-350-15092018-07-06
Bistos Co., Ltd.
Hi-bebe 2018-07-06
Bistos Co., Ltd.
Duo Double Electric Breast Pump 2018-07-06
Daniel Lim [Bistos Co., Ltd.]
Hi bebe plus, BT-1002016-09-07
Daniel Lim [Bistos Co., Ltd.]
Duo Double Electric Breast Pump, MD-20.22016-09-07
BISTOS CO., LTD.
Hi Bebe Plus2016-09-01
Daniel Lim [Bistos Co., Ltd.]
BT-220L Prenatal monitoring system2015-07-13
Daniel Lim [Bistos Co., Ltd.]
BT-220C Prenatal monitoring system2015-07-13
Bistos Co., Ltd.
Model BT-220L And BT-220C2015-07-09
Daniel Lim [Bistos Co., Ltd.]
BT-400 Neonatal Phototherapy2015-03-25
Daniel Lim [Bistos Co., Ltd.]
BT-500 Infant Incubator2014-08-05
BISTOS CO., LTD.
INFANT INCUBATOR2014-07-03
Daniel Lim [Bistos Co., Ltd.]
BT-200 Vascular Doppler2012-08-23
BISTOS CO., LTD.
BT-200V VASCULAR DOPPLER2012-08-02
Daniel Lim [Bistos Co., Ltd.]
Head-worn light BT-4102011-06-14
Daniel Lim [Bistos Co., Ltd.]
BT-3502011-05-19
Daniel Lim [Bistos Co., Ltd.]
BT-3502011-05-19
BISTOS CO., LTD.
BT-3502011-05-13
Daniel Lim [Bistos Co., Ltd.]
Hi-bebe2010-06-16
Daniel Lim [Bistos Co., Ltd.]
Fetal Doppler2010-06-16
Daniel Lim [Bistos Co., Ltd.]
Bistos Co., Ltd.2010-06-16
Daniel Lim [Bistos Co., Ltd.]
BT-200T2010-06-16
BISTOS CO., LTD.
FETAL MONITOR MODEL: BT-200T2010-06-07
Daniel Lim [Bistos Co., Ltd.]
BT-3002007-11-22
Daniel Lim [Bistos Co., Ltd.]
BT-200 Hi Bebe Fetal Doppler2007-11-22
Daniel Lim [Bistos Co., Ltd.]
BT-3002007-11-22
Daniel Lim [Bistos Co., Ltd.]
BT-200 Hi Bebe Fetal Doppler2007-11-22
BISTOS CO., LTD.
FETAL MONITOR, MODELS BT-300 AND BT-2002005-10-04

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020080318868Pusan,South Korea -> Charleston, South CarolinaBREAST PUMP30 PKG
2020080318868Pusan,South Korea -> Charleston, South CarolinaBREAST PUMP30 PKG
2020061370535Pusan,South Korea -> Los Angeles, CaliforniaPATIENT MONITOR47 PKG
202005308013Pusan,South Korea -> Charleston, South CarolinaBREAST PUMP30 PKG
202005308013Pusan,South Korea -> Charleston, South CarolinaBREAST PUMP30 PKG
2020051661404Pusan,South Korea -> Long Beach, CaliforniaMEDICAL APPARATUS 9018.1930 CTN
202003167882Pusan,South Korea -> Charleston, South CarolinaBREAST PUMP30 PKG
202003167882Pusan,South Korea -> Charleston, South CarolinaBREAST PUMP30 PKG
2020031339322Pusan,South Korea -> Long Beach, CaliforniaMEDICAL APPARATUS 9018.191 PKG
2020022537983Pusan,South Korea -> Long Beach, CaliforniaMEDICAL APPARATUS 9018.191 PKG
202002036075Pusan,South Korea -> Charleston, South CarolinaBREAST PUMP20 PKG

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