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Beijing Choice Electronic Technology Co., Ltd.

✓ Record-verifiedregistrations found in 12 marketsEU SRN CN-MF-000005776

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 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

205UDI-DI device records

Class IIa 176Class IIb 29

USUnited StatesFDA openFDA

30listed device types

Class I 7Class II 23Class III 0

plus 59 registration records and 43 510(k)

UKUnited KingdomMHRA PARD

11registered device records

Class IIa 3Class IIb 8

BRBrazilANVISA

9registered devices

Class II 9

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

23 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

11active ARTG entries

IIa 10IIb 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 Union213 raw hits, 8 excluded, 205 confirmed

United States59 registration records, 43 510(k), 0 PMA, 23 excluded

United Kingdom11 confirmed, 5 excluded

Brazil9 confirmed, 0 excluded

Canada0 confirmed, 7 excluded

Manufacturer names merged into this page: BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. · BEIJING CHOICE ELECTRONIC TECHNOLOGY CO.,LTD. · BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000005776
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Wings Medical(U.K.) Limited

FDA 510(k) clearances by year

12007

32008

52009

72010

12011

22012

42013

22014

32015

42016

12017

22018

12021

32022

32023

12024

FDA listed device types

showing 8 of 30

Kit, Test, Pregnancy, Hcg, Over The Counter 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Nebulizer (Direct Patient Interface) 1Bottle, Collection, Vacuum 1Oximeter 1Pad, Heating, Powered 1Electrode, Cutaneous 1Clinical Electronic Thermometer 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06942820422720	Pulse Oximeter	Class IIa
EU	06942820422713	Pulse Oximeter	Class IIa
EU	06942820422683	Pulse Oximeter	Class IIa
EU	06942820422676	Pulse Oximeter	Class IIa
UK	33586	Vital Sign Monitor	Class IIb
UK	17888	Infrared Forehead Thermometer	Class IIa
UK	31321	Oxygen Concentrator	Class IIb
US	K232975	Pulse Oximeter (MD300C228)	2024-06-21
US	K230587	Wrist Pulse Oximeter	2023-11-30
US	K230172	Pulse Oximeter	2023-08-12
BR	80275310062	Oxímetro de Pulso G-Tech	Class II
BR	10349590060	OXIMETRO DE PULSO	Class II
BR	82195309058	Oximetro de pulso	Class II