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Jayfen Health (Malaysia) Sdn Bhd

Malaysia · Klang Selangor · www.jayfenhealth.com

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, United Kingdom — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

4listed device types

Class I 4Class II 0Class III 0

plus 5 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

11registered device records

Class I 3Class IIa 8

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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.

United States5 registration records, 0 510(k), 0 PMA

United Kingdom11 confirmed, 0 excluded

Manufacturer names merged into this page: JAYFEN HEALTH (MALAYSIA) SDN. BHD.

Regulatory identity

UK responsible person: MT Promedt Consulting Ltd

FDA listed device types

Pad, Menstrual, Unscented 1Bedding, Disposable, Medical 1Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile 1Garment, Protective, For Incontinence 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	36306	Brand: Dispo-med All Purpose Sampling Cannula, Size Adult, Male Luer Connector	Class IIa
UK	36306	PRO-Breathe Airway Adapter, Luer Lock Female, 22/15mm	Class IIa
UK	47172	Latex Examination Powder Free Glove	Class I

Jayfen Health (Malaysia) Sdn Bhd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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