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Home›USA›Pt. Maja Agung Latexindo

Pt. Maja Agung Latexindo

USA · City Of Industry
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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
4listed device types
Class I 4Class II 0Class III 0
plus 7 registration records and 11 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 3
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
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 States7 registration records, 11 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: P.T. MAJA AGUNG LATEXINDO · PT. MAJA AGUNG LATEXINDO · PT.MAJA AGUNG LATEXINDO
Same-named companies — This database also contains companies with near-identical names: P.T. MAJA AGUNG LATEXINDO. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
City Of Industry

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

11990
11998
11999
22000
22002
12006
12008
12017
12022

FDA listed device types

Latex Patient Examination Glove 1Polymer Patient Examination Glove 1Surgeon'S Gloves 1Medical Glove, Specialty 1

Registration details (sample)

MarketIdentifierNameClass / date
USK212408Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)2022-05-18
USK161099Powder Free Nitrile Examination Gloves, Black2017-02-23
USK081488POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE2008-08-28
BR81788080029Luvas para procedimentos não cirúrgicos Látex com pó ABL VClass I
BR80808480007Luvas para procedimentos não cirurgicos BCP 100Class I
BR80808480008Luvas para procedimentos não cirúrgicos BCP 200Class I
SAME0000007259SFDAA00001shamrock—

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