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Sign in to claim this brandOpsens Inc.
Canada·CA-MF-000018361
Last updated September 17, 2026
Information
- Country
- Canada
- Address
- 750, Boulevard du Parc Technologique, Quebec, Canada
- Website
- www.opsens.com
- —
- —
- [email protected]
- Phone
- 418-781-0333
- PRRC Contact
- Marc Chaunet
- EUDAMED SRN
- CA-MF-000018361
- FDA FEI Number
- 3008061490
- DUNS Number
- 253717946
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OptoWire Deux Pressure Guidewire with Gauge Connector | F1011 | EUDAMED | Class III | Active |
| Opto Wire and OptoMonitor System | K142598 | FDA 510(k) | Class II | Active |
| PacePro Wire | K240864 | FDA 510(k) | Class II | Active |
| SavvyWire | K213854 | FDA 510(k) | Class II | Active |
| OptoMonitor 3 | F2300 | EUDAMED | Class IIb | Active |
| OptoWire III Pressure Guidewire | F1031 | EUDAMED | Class III | Active |
| OptoMonitor | F2000 | EUDAMEDFDA 510(k) | Class IIb | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Opsens US