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Guangdong Biolight Meditech Co., Ltd

✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000006333

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

199UDI-DI device records

Class I 70Class IIa 20Class IIb 109

USUnited StatesFDA openFDA

19listed device types

Class I 0Class II 19Class III 0

plus 17 registration records and 21 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class IIa 2Class IIb 7

BRBrazilANVISA

1registered devices

Class II 1

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class III 1

2 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

IIa 3IIb 2

HKHong KongMDACS

6valid listings

Class II 3Class III 3

ILIsraelAMAR

19registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 1Class 2b 3

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union199 raw hits, 0 excluded, 199 confirmed

United States17 registration records, 21 510(k), 0 PMA, 2 excluded

United Kingdom9 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: GUANGDONG BIOLIGHT MEDITECH CO., LTD · GUANGDONG BIOLIGHT MEDITECH CO., LTD. · GUANGDONG BIOLIGHT MEDITECH CO LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000006333
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Etheria Medical Ltd

FDA 510(k) clearances by year

12008

32010

12011

32012

12013

42014

52016

22017

12019

FDA listed device types

showing 8 of 19

Detector And Alarm, Arrhythmia 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) 1Analyzer, Gas, Oxygen, Gaseous-Phase 1Oximeter 1Continuous Measurement Thermometer 1Dislodger, Stone, Basket, Ureteral, Metal 1Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06932562301872	Syringe Pump	Class IIb
EU	06932562301865	Infusion Pump	Class IIb
EU	06932562301858	Infusion Pump	Class IIb
EU	06932562301841	Infusion Pump	Class IIb
UK	13215	Infusion Pump used for intravenous infusion administration	Class IIb
UK	13217	Syringe Pump used for intravenous injection administration	Class IIb
UK	38470	Central Monitoring System	Class IIb
US	K181919	Patient Monitor	2019-04-05
US	K170514	Central Monitoring System	2017-05-24
US	K162234	Truscope Ultra Patient Monitor	2017-01-04
BR	81838410002	OXIMETRO DE PULSO DE DEDO	Class II
CA	90605	PATIENT MONITOR	Class III

Guangdong Biolight Meditech Co., Ltd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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