HomeCanadaOpsens, Inc.

Opsens, Inc.

Canada · Quebec
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, South Korea, Australia, Hong Kong, 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
4listed device types
Class I 0Class II 4Class III 0
plus 10 registration records and 11 510(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
5 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
3active ARTG entries
Class III 2IIa 1
HKHong KongMDACS
2valid listings
Class IV 2
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 States10 registration records, 11 510(k), 0 PMA
Manufacturer names merged into this page: OPSENS INC. · OPSENS, INC

Company information

Country
Canada
City
Quebec

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

12015
22016
12019
32020
12022
12024
12025
12026

FDA listed device types

Adjunctive Cardiovascular Status Indicator 1Wire, Guide, Catheter 1Transducer, Pressure, Catheter Tip 1Electrode, Pacemaker, Temporary 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251367OptoMonitor 32026-01-16
USK241418OptoMonitor 32025-02-12
USK240864PacePro Wire2024-05-24

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