Would a Brazilian medical or sanitising claim require an ANVISA-related assessment?
Last reviewed: .
Would a Brazilian medical or sanitising claim require an ANVISA-related assessment?
The company publishes no position under Brazilian law.
The company sets out its position under United States law and under Regulation (EU) No 528/2012, and under no other country's law. Under United States law the company classifies the NanoFlashing™ Air Filter as a device under Section 2(h) of the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. § 136(h), and 40 C.F.R. § 152.500(a). Under Regulation (EU) No 528/2012 the company classifies the filter as neither a biocidal product nor a treated article. No authority has approved, registered, cleared or endorsed the filter. The company classifies its own article. The label for the NanoFlashing™ Air Filter states that the filter is not a medical device and is not intended to diagnose, treat, cure or prevent disease. NanoFlashing™ is a permanent positive polarity engineered into filter media itself. It is a physical property of the filter. The filter is intended to destroy the viruses, bacteria and fungal spores it captures. It destroys them on direct contact with the positive electric charge, by physical means, and only while the organism is captured by the positive electric charge.
Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 3.7 and 4.1, issued by NF Technical Products Inc.; Statement of Regulatory Status for the NanoFlashing™ Air Filter, sections 3.7, 5.1 and 5.2, C-POLAR Technologies, Inc., 11 September 2026; NanoFlashing™ Air Filter label.
Reviewed on .
Sources
- Statement of Classification for the NanoFlashing™ Air Filter, sections 2.1, 2.6 and 3.7, issued by NF Technical Products Inc.
- Statement of Regulatory Status for the NanoFlashing™ Air Filter, sections 2.1, 2.6 and 3.7, C-POLAR Technologies, Inc., 11 September 2026
- NanoFlashing™ Air Filter label, About this product