Would a CDSCO application treat a replacement cartridge as a separately licensed device or an accessory covered by a host-device licence?
Last reviewed: .
Would a CDSCO application treat a replacement cartridge as a separately licensed device or an accessory covered by a host-device licence?
The company publishes no position under Indian law and no classification of a cartridge or an accessory under it.
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 Terms of Use state that, as of their effective date, the Water, Textiles, Food packaging, and Medical devices chapters describe Research Applications, and that they do not describe finished products currently available from C-POLAR for those uses. 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 technology; the name, rating and sale of a product that carries it are set by that product's maker and seller.
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; C-POLAR — Terms of Use, section 4, https://cpolar.tech/terms/; NanoFlashing™ Air Filter label. A question about a particular product or market can be sent to [email protected] or +1 604 630 6830.
Reviewed on .
Sources
- Statement of Classification for the NanoFlashing™ Air Filter, section 3.7, issued by NF Technical Products Inc.
- Statement of Regulatory Status for the NanoFlashing™ Air Filter, section 3.7, C-POLAR Technologies, Inc., 11 September 2026
- C-POLAR — Terms of Use, sections 4 and 6
- NanoFlashing™ Air Filter label, About this product