Data / Medical devices / Canada / Sheer Simple Laboratories Inc.
Sheer Simple Laboratories Inc.: FDA-registered device maker in Victoria British Columbia, Canada, 1 510(k) clearance
Sheer Simple Laboratories Inc. is registered with the FDA (registration 3024787082) in Victoria British Columbia, Canada. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 2, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024787082
- Address
- Bridge Street, Victoria British Columbia, Canada, V8T 4S9
- Owner or operator
- Sheer Simple Laboratories Inc. (10095774)
- Roles
- Exporter to the US, Foreign private label distributor
- First device listed
- April 27, 2026
- Registered through
- 2026
- Brand names listed
- Joni Description Products: Menstrual and Leak-proof products, Tosama 100% Organic Cotton Menstrual Tampon
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Garment, Protective, For Incontinence | EYQ | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Exporter to the US, Foreign private label distributor | 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 |
|---|---|---|---|---|---|---|
| July 2, 2015 | K151170 | Tosama 100% Organic Cotton Menstrual Tampon | HEB | Substantially Equivalent | Tosama, D.O.O. | accessdata.fda.gov |
Compare with other makers
- All makers of Garment, Protective, For Incontinence
- All makers of Pad, Menstrual, Unscented
- All makers of Tampon, Menstrual, Unscented
Updated July 2, 2015. 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.