HomeUSAPRESTIGE MEDICAL, LTD.

PRESTIGE MEDICAL, LTD.

USA · Blackburn
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 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
11listed device types
Class I 6Class II 5Class III 0
plus 17 registration records and 1 510(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
1 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
Class I 3
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 States17 registration records, 1 510(k), 0 PMA, 11 excluded
Manufacturer names merged into this page: Prestige Medical · PRESTIGE MEDICAL, LTD. · PRESTIGE MEDICAL

Company information

Country
USA
City
Blackburn

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 · K962903

FDA listed device types

showing 8 of 11
System, Measurement, Blood-Pressure, Non-Invasive 1Sterilizer, Steam 1Blood Pressure Cuff 1Oximeter 1Continuous Measurement Thermometer 1Stethoscope, Manual 1Light, Examination, Medical, Battery Powered 1Percussor 1

Registration details (sample)

MarketIdentifierNameClass / date
USK962903PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE1998-03-03

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