Lepu Medical Technology Beijing Co L T D

FDA Filings

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

CHINA

SHENZHEN STOCK EXCHANGE

300003

DUNS 529853921

FDA Registration(s)

• Registration Number: 3011564431
• FEI Number: 3011564431
• Name: Macro Mu
• Owner & Operator: Lepu Medical Technology (Beijing) Co., Ltd
• Contact Address: No.37 Chaoqian Rd., Changping District; Beijing CN-11 Beijing 102200 CN
• Official Correspondent:
  • Xiangdan Jin
  • 086-10-80123515-x
• US Agent:
  • Macro Mu
  • MID-LINK INTERNATIONAL CO., Ltd
  • 360 3257028
  • us.agent@mid-link.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2219 Rimlang Drive, Suite 301 Bellingham-Barkley Villiage; Bakerview, WA 98226 US
• Establishment Type: Sterilize Medical Device for Another Party (Contract Sterilizer)

• Registration Number: 3008002401
• FEI Number: 3008002401
• Name: LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
• Owner & Operator: Lepu Medical Technology (Beijing) Co., Ltd
• Contact Address: No.37 Chaoqian Rd., Changping District; Beijing CN-11 Beijing 102200 CN
• Official Correspondent:
  • Xiangdan Jin
  • 086-10-80123515-x
• US Agent:
  • Macro Mu
  • MID-LINK INTERNATIONAL CO., Ltd
  • 360 3257028
  • us.agent@mid-link.net
• Importing Logistics Registration:
  • Importer: Carewell Health Inc.
  • Address: 960 Wayne Avenue Suite 740 ; Silver Spring, MD 20910 UNITED STATES
• Importing Logistics Registration:
  • Importer: Prism Genomic Medicine, Inc.
  • Address: 655 Travis Street Suite #840 ; Houston, TX 77030 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No.37 Chaoqian Rd. Changping District; Beijing Beijing, 102200 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 16936733736156 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736149 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736132 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736125 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736118 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736101 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736095 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736088 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736071 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736064 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736057 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736040 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736033 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736026 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736019 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733736002 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733735999 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733735982 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733735975 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733735968 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733735951 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733735944 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733735937 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733735920 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733735890 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
GUDID 16936733735883 Lepu Medical Technology (Beijing) Co.,Ltd.	Angioway	2020-05-06
QKO LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	SARS-CoV-2 Antibody Test (colloidal gold immunochromatography)	2020-03-25
GUDID 16936733740924 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740917 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740900 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740894 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740887 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740870 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740863 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740856 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740849 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740832 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740825 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740818 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740801 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740795 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740788 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740771 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740191 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740184 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740177 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740160 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740153 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740146 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740139 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740122 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740115 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740108 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733740009 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733739997 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733739980 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733739973 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733739966 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733739959 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733739942 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733739935 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733739874 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733739867 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733739850 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733738044 Lepu Medical Technology (Beijing) Co.,Ltd.	Brilliant	2019-06-07
GUDID 16936733737573 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737559 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737535 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737511 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737481 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737375 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737368 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737351 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737344 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737337 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737320 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737313 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737306 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737290 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737283 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737276 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733737269 Lepu Medical Technology (Beijing) Co.,Ltd.	Shoocin	2019-06-07
GUDID 16936733736811 Lepu Medical Technology (Beijing) Co.,Ltd.	ULTRASKIN	2018-12-31
GUDID 16936733736774 Lepu Medical Technology (Beijing) Co.,Ltd.	ULTRASKIN	2018-12-31
GUDID 16936733737078 Lepu Medical Technology (Beijing) Co.,Ltd.	ULTRASKIN	2018-06-28
GUDID 16936733737054 Lepu Medical Technology (Beijing) Co.,Ltd.	ULTRASKIN	2018-06-28
GUDID 16936733736941 Lepu Medical Technology (Beijing) Co.,Ltd.	ULTRASKIN	2018-06-28
GUDID 16936733736927 Lepu Medical Technology (Beijing) Co.,Ltd.	ULTRASKIN	2018-06-28
GUDID 16936733736873 Lepu Medical Technology (Beijing) Co.,Ltd.	ULTRASKIN	2018-06-28
GUDID 16936733736859 Lepu Medical Technology (Beijing) Co.,Ltd.	ULTRASKIN	2018-06-28
PMN K172099 | DYB Macro Mu [Lepu Medical Technology (Beijing) Co., Ltd]	Shoocin Introducer Kit	2018-05-11
PMN K172099 | DYB LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	Shoocin Introducer Kit	2018-05-11
PTL Macro Mu [Lepu Medical Technology (Beijing) Co., Ltd]	Guidewire Torquer	2018-05-11
PTL Macro Mu [Lepu Medical Technology (Beijing) Co., Ltd]	Guidewire Introducer	2018-05-11
PTL LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	Guidewire Torquer	2018-05-11
PTL LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	Guidewire Introducer	2018-05-11
DTL Macro Mu [Lepu Medical Technology (Beijing) Co., Ltd]	Y-Hemostasis Valve	2018-05-11
DTL LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	Y-Hemostasis Valve	2018-05-11
PMN K141707 | DQX Macro Mu [Lepu Medical Technology (Beijing) Co., Ltd]	ULTRASKIN	2018-05-03
PMN K141707 | DQX LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	ULTRASKIN	2018-05-03
PTM Macro Mu [Lepu Medical Technology (Beijing) Co., Ltd]	Inflation Device	2018-05-03
PTM LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	Inflation Device	2018-05-03
GUDID 06936733770320 Lepu Medical Technology (Beijing) Co.,Ltd.	Vasc Band	2018-03-29
PMN K172331 Lepu Medical Technology (Beijing) Co., Ltd.	Type I, Type II, Type III, Type IV	2018-03-02
PMN K172099 Lepu Medical Technology (Beijing) Co., Ltd.	Shoocin Introducer Kit	2017-10-05
PMN K141707 LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.	ULTRASKIN HYDROPHILIC GUIDE WIRE	2015-01-21
PMN K142359 | DXC Macro Mu [Lepu Medical Technology (Beijing) Co., Ltd]	Vasc Band	2014-11-18
PMN K142359 | DXC LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	Vasc Band	2014-11-18
PMN K142359 Lepu Medical Technology (Beijing) Co., LTD	Vasc Band Hemostat	2014-10-23
PMN K123475 | DYB Macro Mu [Lepu Medical Technology (Beijing) Co., Ltd]	ShoocinTM Introducer Kit	2014-07-16
PMN K123475 | DYB LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	ShoocinTM Introducer Kit	2014-07-16
PMN K123475 LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	SHOOCIN INTRODUCER KIT	2014-02-03
PMN K123473 LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	HOPER PTCA BALLOON CATHETER	2013-08-13
PMN K111837 | DXC Macro Mu [Lepu Medical Technology (Beijing) Co., Ltd]	Rayband Radial Artery Compression Tourniquet	2011-11-14
PMN K111837 | DXC LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	Rayband Radial Artery Compression Tourniquet	2011-11-14
PMN K111837 LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	RADIAL ARTERY COMPRESSION TOURNIQUET	2011-09-27