HomeChinaGuilin Latex Factory

Guilin Latex Factory

China · Guilin
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 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
pendingnot queried
USUnited StatesFDA openFDA
2510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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
9 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States0 registration records, 2 510(k), 0 PMA, 14 excluded
Brazil2 confirmed, 8 excluded
Saudi Arabia0 confirmed, 5 excluded
Canada0 confirmed, 5 excluded
Manufacturer names merged into this page: GUILIN LATEX FACTORY · WINNER GUILIN LATEX CO., LTD.
Same-named companies — This database also contains companies with near-identical names: Beijing Latex Factory, Shanghai Latex Factory. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Guilin

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 · K893162
12000 · K994118

Registration details (sample)

MarketIdentifierNameClass / date
USK994118OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS2000-08-14
USK893162PATIENT EXAMINATION GLOVES1989-08-10
BR80686369142LUVAS CIRÚRGICAS ESTÉREIS GOBON, LÁTEX NATURAL, COM PÓClass II
BR80686369143LUVAS CIRÚRGICAS ESTÉREIS GOBON, LÁTEX NATURAL, SEM PÓClass II

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