Guangdong Biolight Meditech Co., Ltd.

Address:No.2 Innovation First Road, Technology Innovation Coast,Zhuhai Guangdong,CN

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Oximeter (DQA) (5) Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (2) Thermometer, Electronic, Clinical (FLL) (2) Electrocardiograph (DPS) (1)

Premarket Exempt

No Yes

Clear

Fingertip Pluse Oximter - 06932562310003 Catalog Number :

Device Class : 2

Duns Number: 530120146

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Fingertip Pluse Oximeter - 06932562310010 Catalog Number :

Device Class : 2

Duns Number: 530120146

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Fingertip Pluse Oximeter - 06932562310027 Catalog Number :

Device Class : 2

Duns Number: 530120146

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Electronic Thermoneter - 06932562310034 Catalog Number :

Device Class : 2

Duns Number: 530120146

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Electronic thermoneter - 06932562310041 Catalog Number :

Device Class : 2

Duns Number: 530120146

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Handheld Pulse Monitor - 06932562310058 Catalog Number :

Device Description : The monitor is indicated for spot checking of functional arterial SpO2(BLT-SpO2) The monitor is indicated for spot checking of functional arterial SpO2(BLT-SpO2), and pulse rate of patient.

Device Class : 2

Duns Number: 530120146

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Handheld Pulse Oximeter - 06932562310065 Catalog Number :

Device Class : 2

Duns Number: 530120146

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Digital Electrocardigraph - 06932562310072 Catalog Number :

Device Class : 2

Duns Number: 530120146

Premarket Exempt : No

Product Code : DPS

Prescription Use : No

Device Count : 1

Patient Monitor - 06932562310089 Catalog Number :

Device Description : The Monitor is intended to be used for monitoring, displaying, reviewing, storin The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG(3-lead, 5-lead, 12-lead selectable), arrhythmia detection, ST segment analysis, HR, Respiration Rate(RESP), TEMP, Pulse Oxygen Saturation(BLT-SpO2), PR, NIBP, IBP, CO2, Anesthetic Gas(AG), Impedance Cardiograph(ICG), CSI, BIS, SpHb, SpCO, and SpMet

Device Class : 2

Duns Number: 530120146

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

Patient Monitor - 06932562310096 Catalog Number :

Device Description : The Monitor is intended to be used for monitoring, displaying, reviewing, storin The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG(3-lead, 5-lead, 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate(HR), Respiration Rate(RESP), Temperature(TEMP), Pulse Oxygen Saturation(Masimo-SpO2), Pulse Rate(PR), Non-invasive Blood Pressure(NIBP), Invasive Blood Pressure(IBP), Carbon dioxide(CO2), Anesthetic Gas(AG), Impedance Cardiograph(ICG), Cerebral State Index(CSI), Bispectral Index(BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin(SpCO), and Methemoglobin(SpMet).

Device Class : 2

Duns Number: 530120146

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

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