Data / Medical devices / Canada / Diva International, Inc.
Diva International, Inc.: FDA-registered device maker in KITCHENER Ontario, Canada, 2 510(k) clearances
Diva International, Inc. is registered with the FDA (registration 3005113602) in KITCHENER Ontario, Canada. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 21, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005113602
- Address
- Glasgow Street, KITCHENER Ontario, Canada, N2G 4X8
- Owner or operator
- Diva International Inc (9072098)
- Roles
- Exporter to the US, Foreign private label distributor, Repackager or relabeler, Specification developer
- First device listed
- February 7, 2008
- Registered through
- 2026
- Brand names listed
- Diva Biome Balancer Applicator, Diva Cramp Care Patch, Diva Disc, Diva Hot Flash Patch, Diva PL Model A, Diva PL Model B, Diva Reusable Underwear, DivaCup Model 0 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Vaginal | HGD | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Cup, Menstrual | HHE | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Reusable | NUQ | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| November 21, 2018 | K182027 | Wet Organics Personal Lubricant | NUC | Substantially Equivalent | Trigg Laboratories Dba Wet International | accessdata.fda.gov |
| July 16, 2002 | K021356 | THE DIVACUP MENSTRUAL SOLUTION | HHE | Substantially Equivalent | Diva International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Lubricant, Personal
- All makers of Applicator, Vaginal
- All makers of Pad, Menstrual, Reusable
- All makers of Cup, Menstrual
Updated November 21, 2018. 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.