HomeUSATEMREX CORPORATION

TEMREX CORPORATION

USA · Freeport
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, South Korea, Australia, Israel — 6 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
16listed device types
Class I 9Class II 7Class III 0
plus 28 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
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
6 including historic records
TWTaiwanTFDA
5valid device licences
Class I 5
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
Class I 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States28 registration records, 2 510(k), 0 PMA
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: TEMREX CORP. · TEMREX CORPORATION

Company information

Country
USA
City
Freeport

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

11985 · K851030
12012 · K123273

FDA listed device types

showing 8 of 16
Cement, Dental 1Catheter And Tip, Suction 1Liner, Cavity, Calcium Hydroxide 1Material, Tooth Shade, Resin 1Varnish, Cavity 1Resin, Root Canal Filling 1Agent, Tooth Bonding, Resin 1Spectacle, Magnifying 1

Registration details (sample)

MarketIdentifierNameClass / date
USK123273HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)2012-12-07
USK851030TEMREX-DENTIN VARNISH1985-06-20

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