What complete US regulatory history was supplied if the applicant relies on foreign regulatory experience here?
Last reviewed: .
What complete US regulatory history was supplied if the applicant relies on foreign regulatory experience here?
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. What the company holds for the United States is its Statement of Classification and its label, and for the European Union its Statement of Regulatory Status, dated 11 September 2026.
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.
Reviewed on .
Sources
- Statement of Classification for the NanoFlashing™ Air Filter, sections 1.3 and 3.7, issued by NF Technical Products Inc.
- Statement of Regulatory Status for the NanoFlashing™ Air Filter, sections 1.3 and 5.2, C-POLAR Technologies, Inc., 11 September 2026