Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007305624

FEI Number

3007305624

Entity Name

GUANGDONG BIOLIGHT MEDITECH CO., LTD

City/State/Country

Zhuhai Guangdong, CN

Establishment Address

No.9 Yonghe Road, Hi-tech Zone, Zhuhai Guangdong 519085, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangdong Biolight Meditech Co., Ltd (Owner Number: 10027195)

Owner / Operator Contact Address

No.2 Innovation First Road, Technology, Innovation Coast, Hi-tech Zone, Zhuhai, CN-GD 519085, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101694

PMA Number

N/A

All Registered Proprietary Names

Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor Truscope Classic,Truscope II,Truscope MINI patient monitor Fingertip Pulse Oximeters M70A, M70B,M70C M8000A, M9000A Patient Monitor TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor M69, M7000, M8000, M9000 Patient Monitor M700 Handheld Pulse Oximeter M70 Fingertip Pulse Oximeter Vital Signs Monitor VS1 Vital Signs Monitor V6 Vital Signs Monitor PMVSM5000 Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D AnyView A8,AnyView A6,AnyView A5, AnyView A3,Q2,Q3,Q4,Q5,Q6,Q7 Patient monitor V9 Vital Signs Monitor PMVSM9000 Vital Signs Monitor M50, M50A, M50L oximeter GPD-PO1GR01C AnyView A8, AnyView A6 and M9500 Patient Monitor ARGUS LSM Pro, ARGUS LSM Patient Monitor TRUSCOPE classic Patient Monitor WBP100,WBP201,WBP202 Electronic Sphygmomanometer AnyView A8, AnyView A6, AnyView A5, AnyView A3 patient monitor PATIENT MONITOR M8500 M800, ARGUS OXM plus Handheld Pulse Oximeter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-08-29
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2013-08-29
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2013-08-29
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2013-08-29
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2013-08-29
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2013-08-29
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2013-08-29
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2013-08-29
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-08-29
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-08-29
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2013-08-29
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2013-08-29
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2013-08-29
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2013-08-29
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2012-02-16
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2010-04-11
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2010-04-11
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2010-04-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2010-04-11
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2010-04-11
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2010-04-11
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-04-11
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-04-11
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-10-11
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2016-03-02
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-03-02
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2014-09-19
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2019-07-01
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2019-08-21
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-10-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2010-10-30
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2010-10-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-09-06
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2012-07-12
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2011-11-08
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-09-12

Official Correspondent

Jinyuan Yan

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Guangdong Biolight Meditech Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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3013418500	Quintana Supply, a division of Thomas Scientific	Haverhill, MA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007305624. Last updated year: 2026. Please use registration number 3007305624 when referencing this establishment in official correspondence.