Data / Medical devices / Canada / Resilia Inc.
Resilia Inc.: FDA-registered device maker in Moncton New Brunswick, Canada, 2 510(k) clearances
Resilia Inc. is registered with the FDA (registration 3011529681) in Moncton New Brunswick, Canada. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 3, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011529681
- Address
- 644 Main Street Suite S400, Moncton New Brunswick, Canada, E1C 1E2
- Owner or operator
- Resilia Inc. (10048054)
- Roles
- Complaint file establishment, Foreign private label distributor, Specification developer
- First device listed
- December 7, 2020
- Registered through
- 2026
- Brand names listed
- Uresta, Water-Based Lubricant for Uresta
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Patient | KMJ | 1 | Foreign private label distributor | accessdata.fda.gov |
| Pessary, Vaginal | HHW | 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 |
|---|---|---|---|---|---|---|
| April 3, 2024 | K233548 | Uresta® | HHW | Substantially Equivalent | Resilia, Inc. | accessdata.fda.gov |
| January 14, 2009 | K083769 | MODIFICATION TO URESTA PESSARY | HHW | Substantially Equivalent | Eastmed, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 3, 2024. 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.