Sysmed China Co L T D

FDA Filings

This page includes the latest FDA filings for Sysmed China 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: 3010440667
• FEI Number: 3010440667
• Name: Marco Mu
• Owner & Operator: SYSMED (CHINA) CO., LTD
• Contact Address: 11-2-3, No.17, Wensu Street, Hunnan New ; Shenyang CN-21 Liaoning 110171 CN
• Official Correspondent:
  • Yu Meng
  • 86-024-23970169-x
• US Agent:
  • Marco Mu
  • MID-LINK INTERNATIONAL CO., LTD
  • 360 3257028
  • 360 9253199
  • us.agent@mid-link.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2219 Rimland Dr. Suite 301 ; Bellingham, WA 98226 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 06955623000033 SYSMED (CHINA) CO.,LTD	Oxygen Concentrator	2020-12-17
GUDID 06955623000019 SYSMED (CHINA) CO.,LTD	Oxygen Concentrator	2020-12-03
PMN K192177 SysMed (China) Co., Ltd	SysMed S/T	2020-11-25
PMN K172234 | CAW Marco Mu [SYSMED (CHINA) CO., LTD]	Oxygen Concentrator Models M50	2018-12-19
PMN K172234 | CAW Marco Mu [SYSMED (CHINA) CO., LTD]	Oxygen Concentrator Models M40	2018-12-19
PMN K172234 | CAW Marco Mu [SYSMED (CHINA) CO., LTD]	Oxygen Concentrator Models M30	2018-12-19
PMN K172234 SysMed (China) Co., Ltd	Oxygen Concentrator	2018-06-01

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202007225943	Luda,China (Mainland) -> New York/Newark Area, Newark, New Jersey	OXYGEN CONCENTRATOR	70 PKG
2020033128721	Luda,China (Mainland) -> Los Angeles, California	OXYGEN CONCENTRATOR	9 PKG
2020033030587	Luda,China (Mainland) -> Los Angeles, California	OXYGEN CONCENTRATOR	9 PKG
2020032613641	Pusan,South Korea -> Long Beach, California	OXYGEN CONCENTRATOR CONTRACT NUMBER: SYS-PO-19263	615 CTN
202003185941	Tsingtao,China (Mainland) -> Los Angeles, California	OXYGEN CONCENTRATOR	615 CTN
2020021516826	Pusan,South Korea -> Long Beach, California	OXYGEN CONCENTRATOR CONTRACT NUMBER:SYS-PO-19233	615 CTN
2020021113889	Tsingtao,China (Mainland) -> Los Angeles, California	5L OXYGEN CONCENTRATOR: 15KG W PRESSURE ALARM, LOW FLOW ALARM;1 X CANULA, 1 X HUMIDIFIER CUP SYS-PO-19232	615 CTN
2020011617070	Pusan,South Korea -> Long Beach, California	5L OXYGEN CONCENTRATOR:15KG W PRESSURE ALARM,LOW FLOW ALARM:1XCANULA,1XHUMIDIFIER CUP SYS-PO-19231	615 CTN