Zumax Medical Co L T D

FDA Filings

This page includes the latest FDA filings for Zumax Medical 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: 3006252153
• FEI Number: 3006252153
• Name: ZUMAX MEDICAL CO, LTD.
• Owner & Operator: ZUMAX MEDICAL CO, LTD.
• Contact Address: 36 ZHIYING STREET SUZHOU NEW DISTRICT; SUZHOU CN-32 Jiangsu 215129 CN
• Official Correspondent:
  • XIANGDONG - LI
  • 86-512-66903235-x
• US Agent:
  • Simon Wang
  • Image Systems, Inc
  • 973 7318515
  • 973 6698146
  • isi.medical@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5 ZHIYING STREET SUZHOU NEW DISTRICT; SUZHOU,JIANGSU Jiangsu, 215129 CN
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
HJN ZUMAX MEDICAL CO, LTD.	GL60 Series Illuminator	2019-04-10
HJN ZUMAX MEDICAL CO, LTD.	GL50 Series Illuminator	2019-04-10
HJN ZUMAX MEDICAL CO, LTD.	472E0010	2019-04-10
PUE ZUMAX MEDICAL CO, LTD.	SL200 Handheld slit lamp	2019-04-09
GUDID 06945095536000 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095531999 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095531982 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095531005 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095521990 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095521983 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095521006 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095520986 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095520955 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095520788 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095520078 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095516002 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095512004 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095511991 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095511984 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095511007 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095510888 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095510789 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095510253 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095510000 Zumax Medical Co., LTD	zumax	2018-09-27
GUDID 06945095531203 Zumax Medical Co., LTD	zumax	2018-08-31
GUDID 06945095531180 Zumax Medical Co., LTD	zumax	2018-08-31
GUDID 06945095511304 Zumax Medical Co., LTD	zumax	2018-08-31
GUDID 06945095511205 Zumax Medical Co., LTD	zumax	2018-08-31
GUDID 06945095511182 Zumax Medical Co., LTD	zumax	2018-08-31
GUDID 06945095510192 Zumax Medical Co., LTD	zumax	2018-08-31
GUDID 06945095531302 Zumax Medical Co., LTD	zumax	2018-08-22
HKL ZUMAX MEDICAL CO, LTD.	SR24G Streak Retinoscope	2017-08-28
HKL ZUMAX MEDICAL CO, LTD.	SR24F Streak Retinoscope	2017-08-28
HLI ZUMAX MEDICAL CO, LTD.	DM6GP Ophthalmoscope	2017-08-16
HLI ZUMAX MEDICAL CO, LTD.	DM6G Ophthalmoscope	2017-08-16
HLI ZUMAX MEDICAL CO, LTD.	DM6FP Ophthalmoscope	2017-08-16
HLI ZUMAX MEDICAL CO, LTD.	DM6F Ophthalmoscope	2017-08-16
ELA ZUMAX MEDICAL CO, LTD.	Broken Instrument Removal Kit	2016-08-25
PMN K141392 | DXQ ZUMAX MEDICAL CO, LTD.	SM630	2016-05-04
PMN K141392 | DXQ ZUMAX MEDICAL CO, LTD.	SM620	2016-05-04
PMN K141392 | DXQ ZUMAX MEDICAL CO, LTD.	485-0630	2016-05-04
PMN K141392 | DXQ ZUMAX MEDICAL CO, LTD.	485-0625	2016-05-04
PMN K141392 | DXQ ZUMAX MEDICAL CO, LTD.	485-0081	2016-05-04
PMN K141392 | DXQ ZUMAX MEDICAL CO, LTD.	485-0080	2016-05-04
HLJ ZUMAX MEDICAL CO, LTD.	DW3000	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	DW2000	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	DM6UP	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	DM6UEP	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	DM6UE	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	DM6U	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	DM6DP	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	DM6DEP	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	DM6DE	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	DM6D	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	DM6CE	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	DM6C	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	DM6BEP	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	DM6BE	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	BM800 Binocular Indirect Ophthalmoscope	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	490-0015	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	489 0010	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	488 1000	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	487 1000	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	485 0010	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	467E7860	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	4677860	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	411E0010	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	4110010	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	410E0010	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	410-0010	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	405E7850	2016-04-26
HLJ ZUMAX MEDICAL CO, LTD.	4057850	2016-04-26
HKM ZUMAX MEDICAL CO, LTD.	SR24B STREAK RETINOSCOPES	2006-10-31
HKM ZUMAX MEDICAL CO, LTD.	SR24A STREAK RETINOSCOPES	2006-10-31
HKM ZUMAX MEDICAL CO, LTD.	SR24 STREAK RETINOSCOPES	2006-10-31
HKM ZUMAX MEDICAL CO, LTD.	DW3050	2006-10-31
FSO ZUMAX MEDICAL CO, LTD.	OMS3200 surgical microscope	2006-10-31
FSO ZUMAX MEDICAL CO, LTD.	OMS2650 surgical microscope	2006-10-31
FSO ZUMAX MEDICAL CO, LTD.	OMS2380 surgical microscope	2006-10-31
FSO ZUMAX MEDICAL CO, LTD.	OMS2365 surgical microscope	2006-10-31
FSO ZUMAX MEDICAL CO, LTD.	OMS2360 surgical microscope	2006-10-31
FSO ZUMAX MEDICAL CO, LTD.	OMS2350 surgical microscope	2006-10-31
FSO ZUMAX MEDICAL CO, LTD.	OMS2300 surgical microscope	2006-10-31
FSO ZUMAX MEDICAL CO, LTD.	OMS1950 surgical microscope	2006-10-31
EBA ZUMAX MEDICAL CO, LTD.	HL8300 HEADLIGHT	2006-10-31
EBA ZUMAX MEDICAL CO, LTD.	HL8200 HEADLIGHT	2006-10-31
EBA ZUMAX MEDICAL CO, LTD.	HL8000 HEADLIGHT	2006-10-31
EBA ZUMAX MEDICAL CO, LTD.	HEADLIGHTS	2006-10-31
HJH ZUMAX MEDICAL CO, LTD.	VARIOUS MODELS BINOCULAR LOUPES	2006-10-24
HJH ZUMAX MEDICAL CO, LTD.	SLT Binocular Loupes	2006-10-24
HJH ZUMAX MEDICAL CO, LTD.	SLH Binocular Loupes	2006-10-24
HJH ZUMAX MEDICAL CO, LTD.	SLF Binocular Loupes	2006-10-24
HJH ZUMAX MEDICAL CO, LTD.	SLE Binocular Loupes	2006-10-24
ERA ZUMAX MEDICAL CO, LTD.	OTOSCOPE	2006-10-24
ERA ZUMAX MEDICAL CO, LTD.	OT8 series otoscopes	2006-10-24

Related Finance Registrations

NCAGE Code	SFWJ7	ZUMAX MEDICAL CO.,LTD
CAGE Code	SFWJ7	ZUMAX MEDICAL CO.,LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020082140270	Shanghai ,China (Mainland) -> Los Angeles, California	OMS2380 SURGICAL MICROSCOPE	5 CTN
2020081850520	Shanghai ,China (Mainland) -> Los Angeles, California	OMS2380 SURGICAL MICROSCOPE	5 CTN
2020073144503	Shanghai ,China (Mainland) -> Los Angeles, California	OMS2380 SURGICAL MICROSCOPE	9 CTN
2020060949010	Shanghai ,China (Mainland) -> Long Beach, California	OMS2380 SURGICAL MICROSCOPE	4 CTN
2019050846713	Shanghai ,China (Mainland) -> Los Angeles, California	OMS2300 SURGICAL MICROSCOPE	2 CTN
2019041623967	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	LAB Z5 MICROSCOPE(WHITE) HL8000 HEADLIGHT	2 PKG
2019033024131	Shanghai ,China (Mainland) -> Oakland, California	LAB Z5 MICROSCOPE(WHITE)	2 PKG
2019022824124	57037 -> New York/Newark Area, Newark, New Jersey	MICROSCOPE	1 CTN