HomeThailandSuretex Limited

Suretex Limited

Thailand · Suratthani
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Russia — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
4listed device types
Class I 0Class II 4Class III 0
plus 23 registration records and 11 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
25 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
10 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
6active ARTG entries
IIa 1IIb 5
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
3active registrations
Class 2b 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.

United States23 registration records, 11 510(k), 0 PMA, 3 excluded
Brazil0 confirmed, 4 excluded
Manufacturer names merged into this page: SURETEX, LTD. · SURETEX LIMITED

Company information

Country
Thailand
City
Suratthani

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

11991
21995
12001
12003
22022
22023
12024
12025

FDA listed device types

Condom, Synthetic 1Condom With Nonoxynol-9 1Condom 1Lubricant, Personal 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252521LifeStyles® HydraFeel Natural Rubber Latex Condom2025-11-18
USK232470Polyisoprene Extra Large Condom2024-05-09
USK23190845 Micron Polyisoprene Condom2023-10-27

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