HomeUSAMEDRX, INC.

MEDRX, INC.

USA · Largo
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Israel — 7 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
3listed device types
Class I 1Class II 2Class III 0
plus 3 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 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
4 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
Class I 3IIa 4
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 States3 registration records, 1 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: MEDRX, INC. · MEDRX INC. · MEDRX INC · MedRx, Inc.

Company information

Country
USA
City
Largo

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

11998 · K981511

FDA listed device types

Calibrator, Hearing Aid / Earphone And Analysis Systems 1Audiometer 1Otoscope 1

Registration details (sample)

MarketIdentifierNameClass / date
USK981511OTO WIZZARD1998-07-24
BR10356029028Audiômetro de triagem KioskClass II
BR10356029007AUDIÔMETRO AVANT A2D+Class II
BR10356020090AUDIÔMETRO AVANT REMClass II
SAME0000004704SFDAA00001MedRx Video Otoscope

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