HomeMalaysiaNulatex Sdn. Bhd.

Nulatex Sdn. Bhd.

Malaysia · Kluang
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Russia — 8 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
1listed device types
Class I 0Class II 1Class III 0
plus 2 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
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
1 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
Class I 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2b 1
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 States2 registration records, 3 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: Nulatex Sdn. Bhd. · NULATEX SDN BHD · NULATEX SDN. BHD.

Company information

Country
Malaysia
City
Kluang

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

12007 · K070937
12013 · K121241
12014 · K132107

FDA listed device types

Condom 1

Registration details (sample)

MarketIdentifierNameClass / date
USK132107MALE LATEX CONDOM2014-03-07
USK121241MALE LATEX CONDOM2013-02-14
USK070937MULTIPLE BRAND MALE LATEX CONDOM2007-09-21
BR80722800014Protetor para sonda de Ultrassom MedPexClass I

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