Optec International Inc (OPTI)

[Olderandwiser]

BIOMSK brochure, and FDA status:

Brochure: https://navitihealth.com/wp-content/uploads/sites/31/2020/06/Biomsk-Presentation-ENGLISH-AQ-1.pdf

Says "FDA Certified", but that's not accurate. The BIOMSK parent company GRUPO TEXTIL PROVIDENCIA is FDA registered. But registration for masks such as BIOMSK is optional and doesn't certify any products.

The FDA database includes:

"medical device manufacturers registered with FDA and medical devices listed with FDA. Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA."

My post #46306 has more info and links on BIOMSK and its certification claims.

The good news is that is looks like a high-quality mask with unique properties. I just wish they and OPTEC would not claim/imply FDA "certification".