Manufacturer

Guangdong Biolight Meditech

ChinaLegal entities : Guangdong Biolight Meditech Co., Ltd

Markets : France · Germany · Italy · Poland · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 21 · class II · latest in 2019 · see on the FDA website

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

Website

14 categories, 35 models including 35 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Multi-parameter patient bedside monitors	Z1203020201	Handheld monitor M850 Handheld monitor M860 Handheld monitor M880 Patient monitor G10, G12, G15, G10A, G12A, G15A3 refs Patient monitor M10, Truscope M102 refs 9 others Patient monitor M1000, TRUSCOPE touch mini2 refs Patient monitor M12 patient monitor P1, Truscope P1, LM1,3 refs Patient monitor P12, P15, P18, P22, Truscope P12, Truscope P15, Truscope P18, Truscope P22, LM 15, LM 183 refs Patient monitor Q3, Q5, Q7, TRUSCOPE Ultra Q3, TRUSCOPE Ultra Q5, TRUSCOPE Ultra Q7, PG S30, PG S50, PG S70, LM73 refs Patient monitor S10, S10A2 refs Patient monitor S12, S12A, LM123 refs Vital signs monitor V6 Vital signs monitor V9	IIb MDR	EUDAMED record Report an error
Multi-parameter monitors - consumables	Z1203020285	ECG cable3 refs NIBP cuff3 refs SpO2 sensor SDA-N14/15-100-0326 SpO2 Sensor SRD-A11/15-100-00133 refs	I, IIb MDR	EUDAMED record Report an error
General purpose electrocardiographs	Z12050301	Electrocardiograph E30 Electrocardiograph E65	IIa MDR	EUDAMED record Report an error
Infusion pumps	Z12030301	Infusion Pump BioFusion M500, BioFusion M500 Ex, BioFusion M500 Pro, Evadrop V103 refs Infusion Pump BioFusion S500, BioFusion S500 Neo, BioFusion S500 Ex, BioFusion S500 Pro, BioFusion P500, BioFusion P500 Neo, BioFusion P500 Ex, BioFusion P500 Pro, CODAN 907 V3 refs	IIb MDR	EUDAMED record Report an error
Non-invasive oscillometric blood pressure gauges	Z1203020501	Electronic Sphygmomanometer WBP201, WBP2022 refs Electronic Sphygmomanometer WBP301, WBP3022 refs	IIa MDR	EUDAMED record Report an error
Pulse oximeters	Z1203020408	Fingertip Pulse Oximeter M70, M70A, M70B, M70C, M70D3 refs Pulse Oximeter M800	IIa MDR	EUDAMED record Report an error
Syringe pumps	Z12030302	Syringe Pump BioFusion M300, BioFusion M300 Ex, BioFusion M300 Pro, Evadrop V203 refs Syringe Pump BioFusion S300, BioFusion S300 Neo, BioFusion S300 Ex, BioFusion S300 Pro, BioFusion P300, BioFusion P300 Neo, BioFusion P300 Ex, BioFusion P300 Pro, CODAN 806 S3 refs	IIb MDR	EUDAMED record Report an error
Central information computing systems	Z12030201	Central Monitoring System BioVision2 refs	IIb MDR	EUDAMED record Report an error
Haemodialysis equipment	Z12090201	Haemodialysis equipment D800Plus, D800H, D800S, D503 refs	IIb MDR	EUDAMED record Report an error
Infusion and syringe pump control systems	Z12030306	Infusion Supervision System BioFusion DS100, BioFusion DS100T, BioFusion DS100Pro, BioFusion DS100T Pro, CODAN 200 D, CODAN 400 DD3 refs	IIb MDR	EUDAMED record Report an error
Temperature monitoring cutaneous probes	V03010201	Temperature Probe3 refs	IIa MDR	EUDAMED record Report an error
Video laryngoscopes	Z12021004	Video Laryngoscope BioView C100	I MDR	EUDAMED record Report an error
Vital signs monitoring instruments - consumables	Z12030285	NIBP hose2 refs	I MDR	EUDAMED record Report an error
Vital signs monitoring instruments - hardware accessories	Z12030280	C.O. Extension cable3 refs	I MDR	EUDAMED record Report an error

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