Data / Medical devices / Canada / Duoject Medical Systems, Inc.
Duoject Medical Systems, Inc.: FDA-registered device maker in BROMONT Quebec, Canada, 1 510(k) clearance
Duoject Medical Systems, Inc. is registered with the FDA (registration 9613744) in BROMONT Quebec, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 13, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9613744
- FEI number
- 3002771638
- Address
- 50 Chemin De Gaspe Complex B-5, BROMONT Quebec, Canada, J2L 2N8
- Owner or operator
- Duoject Medical Systems (9038613)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 8, 2014
- Registered through
- 2027
- Brand names listed
- E-Z-Link
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, I.V. Fluid Transfer | LHI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 13, 2014 | K133097 | E-Z LINK | LHI | Substantially Equivalent | Duoject Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 13, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.