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Contec Medical Systems Co., Ltd.

China · Qinhuangdao Hebei Province · www.contecmed.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000007715

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥51, the first 300 verified individually. 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

≥51UDI-DI device records

Class IIb 23IVD C 28

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

22listed device types

Class I 3Class II 19Class III 0

plus 25 registration records and 24 510(k)

UKUnited KingdomMHRA PARD

47registered device records

Class IIa 34Class IIb 9IVD A 4

BRBrazilANVISA

29registered devices

Class I 1Class II 28

31 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

8 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Business type not stated 1

AUAustraliaTGA ARTG

12active ARTG entries

IVD Class 1 1IIa 8IIb 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

40registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 2Class 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 Union790 raw hits, 249 excluded, 51 confirmed. Large result set — only the first 300 verified

United States25 registration records, 24 510(k), 0 PMA, 2 excluded

United Kingdom47 confirmed, 0 excluded

Brazil29 confirmed, 0 excluded

Manufacturer names merged into this page: CONTEC MEDICAL SYSTEMS CO., LTD · CONTEC MEDICAL SYSTEMS CO., LTD. · CONTEC MEDICAL SYSTEMS · CONTEC MEDICAL SYSTEMS CO, LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000007715
EU authorised representative: Prolinx GmbH
UK responsible person: MedPath Limited

FDA 510(k) clearances by year

22008

32009

12010

52011

12014

12015

12016

22017

12018

12019

12020

12021

12022

32024

FDA listed device types

showing 8 of 22

Detector And Alarm, Arrhythmia 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Oximeter 1Electrocardiograph, Ambulatory, With Analysis Algorithm 1System, Imaging, Pulsed Doppler, Ultrasonic 1Electrocardiograph 1Continuous Measurement Thermometer 1Transducer, Ultrasonic, Diagnostic 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06945040109334	Pulse Oximeter	Class IIb
EU	06945040108757	Pulse Oximeter	Class IIb
EU	06945040109389	Pulse Oximeter	Class IIb
EU	06945040104674	Pulse Oximeter	Class IIb
UK	45617	Electronic Sphygmomanometer	Class IIa
UK	45617	OPTYMUS XXI, RODYMUS & CONTEC Electronic Sphygmomanometer	Class IIa
UK	45617	OPTYMUS XXI, RODYMUS & CONTEC Electronic Sphygmomanometer	Class IIa
US	K232893	Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)	2024-06-14
US	K232895	B-Ultrasound Diagnostic System	2024-05-03
US	K232908	Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)	2024-05-02
BR	82351159001	Eletrocardiógrafo	Class II
BR	82818799001	Eletroencefalógrafo KT88	Class II
BR	81313779002	FAMÍLIA DE ELETROCARDIÓGRAFOS MAX ECG	Class II