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Kangfu Medical Equipment Factory Co., Ltd.

China · Yueqing Zhejiang · www.cocet.com

✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000019108

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia, Israel — 7 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

81UDI-DI device records

Class IIa 81

USUnited StatesFDA openFDA

6listed device types

Class I 2Class II 4Class III 0

plus 7 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class IIa 3

BRBrazilANVISA

5registered devices

Class II 5

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

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

IIa 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

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 Union160 raw hits, 79 excluded, 81 confirmed

United States7 registration records, 2 510(k), 0 PMA, 1 excluded

United Kingdom3 confirmed, 1 excluded

Brazil5 confirmed, 0 excluded

Manufacturer names merged into this page: KANGFU MEDICAL EQUIPMENT FACTORY · KANGFU MEDICAL EQUIPAMENT FACTORY · KANGFU MEDICAL EQUIPMENT FACTORY

Regulatory identity

EU manufacturer SRN: CN-MF-000019108
EU authorised representative: Luxus Lebenswelt GmbH
UK responsible person: SUNGO Certification Company Limited

FDA 510(k) clearances by year

12018 · K182652

12021 · K201600

FDA listed device types

Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter 1Clinical Electronic Thermometer 1Continuous Measurement Thermometer 1Hearing Aid, Air-Conduction, Over The Counter 1Hearing Aid, Air-Conduction, Prescription 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06943532401171	OOPSY	Class IIa
EU	06943532401164	Kruidvat	Class IIa
EU	06943532401157	da	Class IIa
EU	06943532401140	da	Class IIa
UK	63711	Infra-red Thermometer	Class IIa
UK	14035	Digital Thermometer	Class IIa
UK	18107	Digital Blood pressure monitors	Class IIa
US	K201600	Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28	2021-12-10
US	K182652	COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10	2018-11-20
BR	82255349001	TERMOMETRO CLÍNICO DIGITAL WINNER MED	Class II
BR	80275319020	Termômetro Digital Infravermelho G-TECH	Class II
BR	10410139017	TERMÔMETRO DIGITAL BIOLAND	Class II

Kangfu Medical Equipment Factory 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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