Data / Medical devices / Canada / Iris + Arlo Inc.
Iris + Arlo Inc.: FDA-registered device maker in Montreal Quebec, Canada, 3 510(k) clearances
Iris + Arlo Inc. is registered with the FDA (registration 3043048216) in Montreal Quebec, Canada. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 22, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043048216
- Address
- 160 Saint Viateur Street East Suite 202, Montreal Quebec, Canada, H2T1A8
- Owner or operator
- Iris + Arlo Inc. (10094264)
- Roles
- Repackager or relabeler
- First device listed
- December 21, 2025
- Registered through
- 2026
- Brand names listed
- Iris + Arlo Menstrual Cup, Iris + Arlo Menstrual Pads and Pantyliners, Iris + Arlo Organic Cotton Cardboard Applicator Tampons, Light, Iris + Arlo Organic Cotton Cardboard Applicator Tampons, Regular, Super and Super Plus, Iris + Arlo Organic Cotton Non-Applicator Tampons
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cup, Menstrual | HHE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| October 22, 2021 | K211775 | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | HEB | Substantially Equivalent | Cotton High Tech S.L. | accessdata.fda.gov |
| March 15, 2019 | K182813 | COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT | HEB | Substantially Equivalent | Cotton High Tech S.L. | accessdata.fda.gov |
| April 29, 2009 | K091084 | MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS | HEB | Substantially Equivalent | Cotton High Tech S.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Cup, Menstrual
- All makers of Tampon, Menstrual, Unscented
- All makers of Pad, Menstrual, Unscented
Updated October 22, 2021. 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.