HomeCanadaPRIMED INSTRUMENTS, INC.

PRIMED INSTRUMENTS, INC.

Canada · Mississauga
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 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
5listed device types
Class I 4Class II 1Class III 0
plus 5 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 3Class II 1
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
3active device licences
Class II 3
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
8active ARTG entries
Class I 7IIa 1
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 States5 registration records, 1 510(k), 0 PMA, 10 excluded
Brazil4 confirmed, 1 excluded
Canada3 confirmed, 1 excluded
Manufacturer names merged into this page: PRIMED INSTRUMENTS, INC. · PRIMED INSTRUMENTS INC. · PRIMED INSTRUMENTS, SIALKOT · PRIMED INSTRUMENTS INC

Company information

Country
Canada
City
Mississauga

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

11993 · K934186

FDA listed device types

Forceps, Biopsy, Non-Electric 1Container, Specimen Mailer And Storage, Non-Sterile 1Accessories, Cleaning Brushes, For Endoscope 1Brush, Scrub, Operating-Room 1Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt 1

Registration details (sample)

MarketIdentifierNameClass / date
USK934186FORCEPS, BIOPSY, GASTROINTESTINAL1993-12-14
BR81987850006INSTRUMENTAIS ARTICULADOS CORTANTES PRIMEDClass I
BR81987850007INSTRUMENTAIS ARTICULADOS NÃO CORTANTES PRIMEDClass I
BR81987850008INSTRUMENTAIS NÃO ARTICULADOS CORTANTESClass I
CA73262CROC SINGLE-USE BIOPSY FORCEPSClass II
CA88157CROC STERILE SINGLE USE RETRIEVAL DEVICEClass II
CA97677CROC STERILE SINGLE-USE CURLEW MULTIPLE BIOPSY FORCEPSClass II

Similar companies

3DBioFibR Inc.
Canada · markets 0
Actuonix Motion Devices Inc.
Canada · markets 0
ARTRON LABORATORIES INC
Canada · markets 8
Averna Powered by Spherea
Canada · markets 0
Batrik Medical Manufacturing, Inc.
Canada · markets 9
bioLytical Laboratories Inc.
Canada · markets 6
Is this your company? Claim the page, add information or report a data error.Claim / report an error →