FDA.report

OPSENS INC.

Matched from indexed company URL: Opsens, Inc.

FDA Registration(s)

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 GUDIDProductPhoneEmail
07540184011131OptoMonitor 3 - AUX interface cable - GE TRAM D15 S4 WB418-781-0333info-medical@opsens.com
07540184011148OptoMonitor 3 - AUX interface cable - GE X5418-781-0333info-medical@opsens.com
07540184011155OptoMonitor 3 - AUX interface cable - Siemens Vibe418-781-0333info-medical@opsens.com
07540184011162OptoMonitor 3 - AUX interface cable - Schwarzer Cardis418-781-0333info-medical@opsens.com
07540184011179OptoMonitor 3 - AUX interface cable - Fysicon QMAPP418-781-0333info-medical@opsens.com

Registered Device Listings

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 codeRegistration listing recordsLatest decision
DXO52026-01-16
DQX52024-05-24

PMN

GUDID

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