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Porex Technologies

USA · Fairburn GA · www.porex.com
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Taiwan — 2 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
4510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
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 States0 registration records, 4 510(k), 0 PMA, 5 excluded
United Kingdom0 confirmed, 1 excluded

Company information

Country
USA
City
Fairburn GA
Website
www.porex.com
Product categories
Materials, Chemicals & Surface TechnologiesMedical-Grade Plastics

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 · K884884
11992 · K922489
11996 · K960859
11997 · K971583

Registration details (sample)

MarketIdentifierNameClass / date
USK971583MEDPOR OCULAR SCREW AND ACCEOSSORIES1997-06-30
USK960859MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES1996-05-29
USK922489MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA1992-09-02

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