FDA.reportPublic FDA data

OPSENS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30080614903008061490OPSENS INC.1N2026-01-01750, Boulevard du Parc Technologique Quebec City CA G1P 4S3

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07540184012220OptoMonitor 3 - Pressure output cable - Nihon Kohden 15 pins800-537-2802CustomerServiceNA@Haemonetics.com
07540184013203OptoMonitor 3 - Direct AO cable - Edwards transducer800-537-2802CustomerServiceNA@Haemonetics.com
07540184013227OptoMonitor 3 - Direct AO cable - Utah transducer800-537-2802CustomerServiceNA@Haemonetics.com
07540184020010OptoMonitor - OpM OU-DU communication cable418-781-0333info-medical@opsens.com
07540184020010OptoMonitor - OpM OU-DU communication cable800-537-2802CustomerServiceNA@Haemonetics.com
07540184020102OptoMonitor - Optical Unit418-781-0333info-medical@opsens.com
07540184020102OptoMonitor - Optical Unit800-537-2802CustomerServiceNA@Haemonetics.com
07540184020201OptoMonitor - Display Unit418-781-0333info-medical@opsens.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1853362066980291K251367OptoMonitor 3DXO2026-01-16
1853362005416218K241418OptoMonitor 3DXO2025-02-12
1853361754699222K240864PacePro WireDQX2024-05-24
1853361704074210K213854SavvyWireDQX2022-09-14
1853361112826022K202943OptoMonitor 3DXO2020-11-24
1853361168304640K193620OptoMonitor 3DXO2020-06-18
1853361259104501K191907OptoWire IIIDQX2020-01-02
1853361668881986K161263OptoMonitor IIDXO2016-09-13
1853361586569271K152991OptoWire DeuxDQX2016-02-11
1853361875474470K142598Opto Wire and OptoMonitor SystemDQX2015-06-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXO52026-01-16
DQX52024-05-24

PMN#

GUDID#

80 records. Showing 1-40. Next