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K-Jump Health Co., Ltd.

Taiwan · New Taipei City · www.kjump.com.tw

✓ Record-verifiedregistrations found in 5 marketsEU SRN TW-MF-000020665

This company has registrations in European Union, United States, Canada, Singapore, Russia — 5 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

25UDI-DI device records

Class IIa 25

USUnited StatesFDA openFDA

5listed device types

Class I 2Class II 3Class III 0

plus 22 registration records and 26 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

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

1active device licences

Class II 1

8 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

3active registrations

Class 2a 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 Union133 raw hits, 108 excluded, 25 confirmed

United States22 registration records, 26 510(k), 0 PMA, 1 excluded

United Kingdom0 confirmed, 2 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: K-JUMP HEALTH CO., LTD. · K-JUMP HEALTH CO., LTD. RENDE PLANT · K-JUMP HEALTH CO., LTD

Regulatory identity

EU manufacturer SRN: TW-MF-000020665
EU authorised representative: Polygreen Germany GmbH

FDA 510(k) clearances by year

11990

21998

11999

12000

12001

32002

12003

22005

22006

12007

32009

12010

22011

12012

12013

12014

12017

12018

FDA listed device types

Clinical Electronic Thermometer 1Nebulizer (Direct Patient Interface) 1System, Measurement, Blood-Pressure, Non-Invasive 1Radioimmunoassay, Luteinizing Hormone 1Cover, Cast 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04252010667506	Polygreen	Class IIa
EU	04252010619512	Polygreen	Class IIa
EU	04252010618102	Polygreen	Class IIa
EU	04252010615309	Polygreen	Class IIa
US	K180714	Probe Covers for Thermometers	2018-09-24
US	K170262	Digital Thermometer	2017-09-28
US	K141505	BASAL DIGITAL THERMOMETER	2014-08-26
CA	88504	POWERED TOOTHBRUSH	Class II

K-Jump Health 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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