Aliform B.V.

Aliform B.V. specializes in general-purpose curettes, such as the Celluleaf. Curettes are tools used in medical procedures to remove tissue or scrape surfaces, often in dermatology, dentistry, or surgical applications. The company’s focus is on this specific category of devices.

Aliform B.V. is headquartered in the United States. This location is relevant for regulatory compliance, manufacturing oversight, and distribution within the US market.

Aliform B.V.’s devices, including the Celluleaf, fall under Class I classification according to FDA regulations. Class I devices are generally considered to pose the lowest risk and often require only general controls (such as good manufacturing practices) for compliance. This classification is based on the device’s intended use and risk profile.

Yes, Aliform B.V.’s devices are included in the FDA Unique Device Identifier (UDI) database. The UDI system helps track and trace medical devices throughout their lifecycle, ensuring transparency in the supply chain and aiding in post-market surveillance. Listing in this registry is a requirement for Class I devices under FDA regulations.