Guangdong Biolight Meditech Co L T D

FDA Filings

This page includes the latest FDA filings for Guangdong Biolight Meditech 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

300246

DUNS 530120146

FDA Registration(s)

• Registration Number: 3007305624
• FEI Number: 3007305624
• Name: Marco Mu
• Owner & Operator: Guangdong Biolight Meditech CO., Ltd
• Contact Address: No.2 Innovation First Road, Technology Innovation Coast, Hi-tech Zone; Zhuhai CN-44 Guangdong 519085 CN
• Official Correspondent:
  • Jinyuan Yan
  • 86-756-3399900-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 06932562310362 Guangdong Biolight Meditech Co., Ltd.	handheld monitor	2024-04-08
GUDID 06932562310355 Guangdong Biolight Meditech Co., Ltd.	Fingertip Pluse Oximeter	2024-04-08
GUDID 06932562310324 Guangdong Biolight Meditech Co., Ltd.	Fingertip Pulse Oximeter	2021-11-10
GUDID 06932562310317 Guangdong Biolight Meditech Co., Ltd.	Fingertip Pulse Oximeter	2021-11-10
GUDID 06932562310348 Guangdong Biolight Meditech Co., Ltd.	Fingertip Pulse Oximeter	2021-07-06
GUDID 06932562310331 Guangdong Biolight Meditech Co., Ltd.	patient monitor	2020-08-18
GUDID 06932562310300 Guangdong Biolight Meditech Co., Ltd.	Vital Signs Monitor	2020-02-06
GUDID 06932562310232 Guangdong Biolight Meditech Co., Ltd.	Patient monitor	2020-02-06
GUDID 06932562310218 Guangdong Biolight Meditech Co., Ltd.	Patient monitor	2020-02-06
GUDID 06932562310201 Guangdong Biolight Meditech Co., Ltd.	Patient monitor	2020-02-06
GUDID 06932562310164 Guangdong Biolight Meditech Co., Ltd.	Patient Monitor	2020-02-06
GUDID 06932562310140 Guangdong Biolight Meditech Co., Ltd.	Patient Monitor	2020-02-06
GUDID 06932562310133 Guangdong Biolight Meditech Co., Ltd.	Patient Monitor	2020-02-06
GUDID 06932562310126 Guangdong Biolight Meditech Co., Ltd.	Patient Monitor	2020-02-06
GUDID 06932562310119 Guangdong Biolight Meditech Co., Ltd.	Patient Monitor	2020-02-06
GUDID 06932562310102 Guangdong Biolight Meditech Co., Ltd.	Patient Monitor	2020-02-06
GUDID 06932562310096 Guangdong Biolight Meditech Co., Ltd.	Patient Monitor	2020-02-06
GUDID 06932562310089 Guangdong Biolight Meditech Co., Ltd.	Patient Monitor	2020-02-06
GUDID 06932562310249 Guangdong Biolight Meditech Co., Ltd.	Electronic Sphygmomanometer	2019-11-08
OCH Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M50L Fingertip Pulse Oximeter	2019-08-21
OCH Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M50 Fingertip Pulse Oximeter	2019-08-21
PMN K181919 | MWI Marco Mu [Guangdong Biolight Meditech CO., Ltd]	V9 Vital Signs Monitor	2019-07-01
PMN K181919 Guangdong Biolight Meditech Co., Ltd.	Patient Monitor	2019-04-05
GUDID 06932562310294 Guangdong Biolight Meditech Co., Ltd.	Fetal monitor	2018-07-06
GUDID 06932562310287 Guangdong Biolight Meditech Co., Ltd.	Fetal monitor	2018-07-06
GUDID 06932562310270 Guangdong Biolight Meditech Co., Ltd.	Fetal monitor	2018-07-06
GUDID 06932562310263 Guangdong Biolight Meditech Co., Ltd.	Fetal monitor	2018-07-06
GUDID 06932562310256 Guangdong Biolight Meditech Co., Ltd.	Fingertip Pluse Oximeter	2018-07-06
GUDID 06932562310225 Guangdong Biolight Meditech Co., Ltd.	Digital Electrocardiograph	2018-07-06
GUDID 06932562310195 Guangdong Biolight Meditech Co., Ltd.	Patient Monitor	2018-07-06
GUDID 06932562310188 Guangdong Biolight Meditech Co., Ltd.	Patient Monitor	2018-07-06
GUDID 06932562310171 Guangdong Biolight Meditech Co., Ltd.	Patient Monitor	2018-07-06
GUDID 06932562310157 Guangdong Biolight Meditech Co., Ltd.	Digital Electrocardigraph	2018-07-06
GUDID 06932562310072 Guangdong Biolight Meditech Co., Ltd.	Digital Electrocardigraph	2018-07-06
GUDID 06932562310065 Guangdong Biolight Meditech Co., Ltd.	Handheld Pulse Oximeter	2018-07-06
GUDID 06932562310058 Guangdong Biolight Meditech Co., Ltd.	Handheld Pulse Monitor	2018-07-06
GUDID 06932562310041 Guangdong Biolight Meditech Co., Ltd.	Electronic thermoneter	2018-07-06
GUDID 06932562310034 Guangdong Biolight Meditech Co., Ltd.	Electronic Thermoneter	2018-07-06
GUDID 06932562310027 Guangdong Biolight Meditech Co., Ltd.	Fingertip Pluse Oximeter	2018-07-06
GUDID 06932562310010 Guangdong Biolight Meditech Co., Ltd.	Fingertip Pluse Oximeter	2018-07-06
GUDID 06932562310003 Guangdong Biolight Meditech Co., Ltd.	Fingertip Pluse Oximter	2018-07-06
PMN K131941 | HGM Marco Mu [Guangdong Biolight Meditech CO., Ltd]	F30,F80,F50,F90 Fetal monitor	2018-04-07
PMN K170514 | MHX Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M6000C Central Monitoring System	2018-03-22
PMN K162234 | MWI Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Ultra Patient Monitor	2018-01-22
PMN K162234 | MWI Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE ultra Q3,TRUSCOPE ultra Q5, TRUSCOPE ultra Q7 Patient Monitor	2018-01-22
PMN K160349 | DXN Marco Mu [Guangdong Biolight Meditech CO., Ltd]	WBP100, WBP201, WBP202 Electronic Sphygmomanometer	2017-09-06
PMN K170514 Guangdong Biolight Meditech Co., Ltd.	Central Monitoring System	2017-05-24
PMN K162234 GUANGDONG BIOLIGHT MEDITECH CO., LTD.	Truscope Ultra Patient Monitor	2017-01-04
PMN K160349 Guangdong Biolight Meditech Co., Ltd.	Electronic Sphygmomanometer	2016-11-03
PMN K153580 GUANGDONG BIOLIGHT MEDITECH CO., LTD.	Central Monitoring System	2016-09-07
PMN K131762 | MWI Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M800 Handheld Monitor	2016-08-31
PMN K131762 | DRT Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M800 Handheld Monitor	2016-08-31
PMN K131762 | DQA Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M800 Handheld Monitor	2016-08-31
PMN K153135 | MWI Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Vital Signs Monitor V6	2016-03-02
PMN K151287 | DQA Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D	2016-03-02
PMN K153135 GUANGDONG BIOLIGHT MEDITECH CO., LTD.	VITAL SIGNS MONITOR	2016-02-25
PMN K152739 | FLL Marco Mu [Guangdong Biolight Meditech CO., Ltd]	WT1,WT2 Electronic Thermometer	2016-02-15
PMN K152739 GUANGDONG BIOLIGHT MEDITECH CO., LTD	Electronic Thermometer	2016-02-09
PMN K151287 GUANGDONG BIOLIGHT MEDITECH CO., LTD.	Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D	2016-01-06
PMN K131858 | DPS Marco Mu [Guangdong Biolight Meditech CO., Ltd]	E30, E40, E65, E70, E80 electrocardiograph	2015-06-11
FLL Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Electronic thermometer	2014-11-21
PMN K131898 | MWI Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Blu12+,Blu15+	2014-09-19
PMN K131898 | MWI Marco Mu [Guangdong Biolight Meditech CO., Ltd]	AnyView A8,AnyView A6,AnyView A5, AnyView A3,Q2,Q3,Q4,Q5,Q6,Q7 Patient monitor	2014-09-19
PMN K131858 GUANGDONG BIOLIGHT MEDITECH CO., LTD.	DIGITAL ELECTROCARDIOGRAPH	2014-06-11
PMN K131762 GUANGDONG BIOLIGHT MEDITECH CO., LTD.	HANDHELD MONITOR	2014-06-06
PMN K131941 GUANGDONG BIOLIGHT MEDITECH CO., LTD	FETAL MONITORS	2014-05-15
PMN K131898 GUANGDONG BIOLIGHT MEDITECH CO., LTD.	A SERIES AND Q SERIES PATIENT MONITORS	2014-02-18
PMN K131763 | MLD Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor	2013-08-29
PMN K131763 | MLD Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Classic,Truscope II,Truscope MINI patient monitor	2013-08-29
PMN K131763 | MHX Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor	2013-08-29
PMN K131763 | MHX Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Classic,Truscope II,Truscope MINI patient monitor	2013-08-29
PMN K131763 | FLL Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor	2013-08-29
PMN K131763 | FLL Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Classic,Truscope II,Truscope MINI patient monitor	2013-08-29
PMN K131763 | DXN Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor	2013-08-29
PMN K131763 | DXN Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Classic,Truscope II,Truscope MINI patient monitor	2013-08-29
PMN K131763 | DSK Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor	2013-08-29
PMN K131763 | DSK Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Classic,Truscope II,Truscope MINI patient monitor	2013-08-29
PMN K131763 | DSI Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor	2013-08-29
PMN K131763 | DSI Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Classic,Truscope II,Truscope MINI patient monitor	2013-08-29
PMN K131763 | DSB Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor	2013-08-29
PMN K131763 | DSB Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Classic,Truscope II,Truscope MINI patient monitor	2013-08-29
PMN K131763 | DRT Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor	2013-08-29
PMN K131763 | DRT Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Classic,Truscope II,Truscope MINI patient monitor	2013-08-29
PMN K131763 | DQA Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor	2013-08-29
PMN K131763 | DQA Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Classic,Truscope II,Truscope MINI patient monitor	2013-08-29
PMN K131763 | CCL Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor	2013-08-29
PMN K131763 | CCL Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Classic,Truscope II,Truscope MINI patient monitor	2013-08-29
PMN K131763 | CCK Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor	2013-08-29
PMN K131763 | CCK Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Classic,Truscope II,Truscope MINI patient monitor	2013-08-29
PMN K131763 | CBS Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor	2013-08-29
PMN K131763 | CBS Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Classic,Truscope II,Truscope MINI patient monitor	2013-08-29
PMN K131763 | CBR Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor	2013-08-29
PMN K131763 | CBR Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Classic,Truscope II,Truscope MINI patient monitor	2013-08-29
PMN K131763 | CBQ Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor	2013-08-29
PMN K131763 | CBQ Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Truscope Classic,Truscope II,Truscope MINI patient monitor	2013-08-29
PMN K131763 GUANGDONG BIOLIGHT MEDITECH CO., LTD.	TRUSCOPE SERIES PATIENT MONITOR	2013-07-15
PMN K120193 | MWI Marco Mu [Guangdong Biolight Meditech CO., Ltd]	AnyView A8, AnyView A6, AnyView A5, AnyView A3 patient monitor	2012-07-12
PMN K120193 GUANGDONG BIOLIGHT MEDITECH CO., LTD	ANY VIEW PATIENT MONITORS	2012-06-29
PMN K113833 GUANGDONG BIOLIGHT MEDITECH CO., LTD	VITAL SIGNS MONITOR	2012-05-01
PMN K112804 | DQA Marco Mu [Guangdong Biolight Meditech CO., Ltd]	Fingertip Pulse Oximeters M70A, M70B,M70C	2012-02-16
PMN K112804 GUANGDONG BIOLIGHT MEDITECH CO., LTD.	FINGERTIP PULSE OXIMETER	2012-01-27
PMN K112803 | MHX Marco Mu [Guangdong Biolight Meditech CO., Ltd]	PATIENT MONITOR M8500	2011-11-08
PMN K112803 GUANGDONG BIOLIGHT MEDITECH CO., LTD.	PATIENT MONITOR	2011-10-24
PMN K102040 | MHX Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE elite-A8, TRUSCOPE elite-A6 Patient Monitor	2010-10-30
PMN K102040 | MHX Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE classic Patient Monitor	2010-10-30
PMN K102040 | MHX Marco Mu [Guangdong Biolight Meditech CO., Ltd]	AnyView A8, AnyView A6 and M9500 Patient Monitor	2010-10-30
PMN K102040 | MHX Marco Mu [Guangdong Biolight Meditech CO., Ltd]	ARGUS LSM Pro, ARGUS LSM Patient Monitor	2010-10-30
PMN K102040 | DXN Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE elite-A8, TRUSCOPE elite-A6 Patient Monitor	2010-10-30
PMN K102040 | DXN Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE classic Patient Monitor	2010-10-30
PMN K102040 | DXN Marco Mu [Guangdong Biolight Meditech CO., Ltd]	AnyView A8, AnyView A6 and M9500 Patient Monitor	2010-10-30
PMN K102040 | DXN Marco Mu [Guangdong Biolight Meditech CO., Ltd]	ARGUS LSM Pro, ARGUS LSM Patient Monitor	2010-10-30
PMN K102040 | DRT Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE elite-A8, TRUSCOPE elite-A6 Patient Monitor	2010-10-30
PMN K102040 | DRT Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE classic Patient Monitor	2010-10-30
PMN K102040 | DRT Marco Mu [Guangdong Biolight Meditech CO., Ltd]	AnyView A8, AnyView A6 and M9500 Patient Monitor	2010-10-30
PMN K102040 | DRT Marco Mu [Guangdong Biolight Meditech CO., Ltd]	ARGUS LSM Pro, ARGUS LSM Patient Monitor	2010-10-30
PMN K102040 GUANGDONG BIOLIGHT MEDITECH CO., LTD.	PATIENT MONITOR	2010-09-24
PMN K101694 | DQA Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M800, ARGUS OXM plus Handheld Pulse Oximeter	2010-09-12
PMN K101694 GUANGDONG BIOLIGHT MEDITECH CO., LTD.	HANDHELD PULSE OXIMETER MODEL M800	2010-09-08
PMN K100046 | MHX Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor	2010-04-11
PMN K100046 | MHX Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M8000A, M9000A Patient Monitor	2010-04-11
PMN K100046 | MHX Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M69, M7000, M8000, M9000 Patient Monitor	2010-04-11
PMN K100046 | FFL Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor	2010-04-11
PMN K100046 | FFL Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M8000A, M9000A Patient Monitor	2010-04-11
PMN K100046 | FFL Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M69, M7000, M8000, M9000 Patient Monitor	2010-04-11
PMN K100046 | DXN Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor	2010-04-11
PMN K100046 | DXN Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M8000A, M9000A Patient Monitor	2010-04-11
PMN K100046 | DXN Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M69, M7000, M8000, M9000 Patient Monitor	2010-04-11
PMN K100046 | DSK Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor	2010-04-11
PMN K100046 | DSK Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M8000A, M9000A Patient Monitor	2010-04-11
PMN K100046 | DSK Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M69, M7000, M8000, M9000 Patient Monitor	2010-04-11
PMN K100046 | DRT Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor	2010-04-11
PMN K100046 | DRT Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M8000A, M9000A Patient Monitor	2010-04-11
PMN K100046 | DRT Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M69, M7000, M8000, M9000 Patient Monitor	2010-04-11
PMN K100046 | DQA Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor	2010-04-11
PMN K100046 | DQA Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M8000A, M9000A Patient Monitor	2010-04-11
PMN K100046 | DQA Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M69, M7000, M8000, M9000 Patient Monitor	2010-04-11
PMN K100046 | CCK Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor	2010-04-11
PMN K100046 | CCK Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M8000A, M9000A Patient Monitor	2010-04-11
PMN K100046 | CCK Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M69, M7000, M8000, M9000 Patient Monitor	2010-04-11
PMN K100046 | BZQ Marco Mu [Guangdong Biolight Meditech CO., Ltd]	TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor	2010-04-11
PMN K100046 | BZQ Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M8000A, M9000A Patient Monitor	2010-04-11
PMN K100046 | BZQ Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M69, M7000, M8000, M9000 Patient Monitor	2010-04-11
PMN K100046 GUANGDONG BIOLIGHT MEDITECH CO., LTD.	M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000	2010-04-08
PMN K081712 | DQA Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M700 Handheld Pulse Oximeter	2008-10-11
PMN K081712 | DQA Marco Mu [Guangdong Biolight Meditech CO., Ltd]	M70 Fingertip Pulse Oximeter	2008-10-11
PMN K081712 GUANGDONG BIOLIGHT MEDITECH CO., LTD.	FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700	2008-09-12