HomeMalaysiaYTY INDUSTRY SDN. BHD.

YTY INDUSTRY SDN. BHD.

Malaysia
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia — 6 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
pendingnot queried
USUnited StatesFDA openFDA
4listed device types
Class I 4Class II 0Class III 0
plus 34 registration records and 27 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 4Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class II 2
7 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
9active ARTG entries
Class I 9
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 States34 registration records, 27 510(k), 0 PMA, 1 excluded
Brazil5 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: YTY INDUSTRY (MANJUNG) SDN. BHD. · YTY INDUSTRY (MANJUNG) SDN BHD · YTY INDUSTRY (MANJUNG) SDN BHD. · YTY INDUSTRY SDN. BHD. · YTY INDUSTRY (MANJUNG) SDN.BHD. · YTY INDUSTRY SDN. BHD
Same-named companies — This database also contains companies with near-identical names: YTY INDUSTRY (MANJUNG) SDN. BHD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Malaysia

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11989
21997
11998
21999
12001
22002
32003
12004
12005
12006
22011
12014
32015
12016
12017
12019
12020
12021
12023

FDA listed device types

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs 1Polymer Patient Examination Glove 1Medical Glove, Specialty 1Fentanyl And Other Opioid Protection Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220644Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs2023-03-25
USK202536Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate2021-08-11
USK200453NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC2020-05-01
BR10201230144LUVA DE NITRILO PARA PROCEDIMENTO NÃO ESTÉRIL (SEM PÓ)Class I
BR81019890002LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO - NÃO ESTÉRIL - EM NITRILO - SEM Class I
BR80256170026Luva de Procedimentos Proced NitrilClass I
SAME0000005481SFDAA00002Safe Gate Nitrile Examination gloves
CA66936PU-RITY POLYURETHANE EXAMINATION GLOVES, POWDER FREEClass II
CA66963BARRIERPRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVESClass II

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