HomeIndonesiaPT. HALONI JANE Tbk

PT. HALONI JANE Tbk

Indonesia · Kabupaten Tangerang · www.halonijane.co.id
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, Australia — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
2510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
4registered devices
Class I 4
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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
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 States0 registration records, 2 510(k), 0 PMA
Brazil4 confirmed, 0 excluded
Manufacturer names merged into this page: PT HALONI JANE TBK

Company information

Country
Indonesia
City
Kabupaten Tangerang
Website
www.halonijane.co.id

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

11994 · K944778
12006 · K062955

Registration details (sample)

MarketIdentifierNameClass / date
USK062955POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE2006-11-09
USK944778LATEX EXAMINATION GLOVES1994-11-17
BR81788080023Luvas para procedimentos não cirúrgicos Látex sem pó ABL IIClass I
BR81788080024Luvas para procedimentos não cirúrgicos Látex com pó ABL IIClass I
BR81365560005LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO DE LÁTEX COM PÓ - PHARMAPLUSClass I

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