HomeIndonesiaPT. INTAN HEVEA INDUSTRY

PT. INTAN HEVEA INDUSTRY

Indonesia · Medan Sumatera Utara
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Taiwan — 3 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 1Class II 0Class III 0
plus 3 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 3
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
pendingnot queried
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 States3 registration records, 2 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: PT. INTAN HEVEA INDUSTRY · PT INTAN HEVEA INDUSTRY

Company information

Country
Indonesia
City
Medan Sumatera Utara

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 · K894480
12011 · K111923

FDA listed device types

Latex Patient Examination Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
USK111923SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE2011-11-04
USK894480PATIENT EXAMINATION GLOVES1989-09-15
BR81229600063LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO DE LÁTEX - COM PÓ - SOFT+AID - EMClass I
BR81229600064LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO DE LÁTEX - SEM PÓ - SOFT+AID - EMClass I
BR81229600065LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO DE NITRILO - SEM PÓ - SOFT+AID - Class I

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