Introduction of Items _ Hydrocolloid Patches
Our main item is a hydrocolloid patch, a product developed to be used on the face or special areas by changing from the hydrocolloid sheet used on wounds. These are called acne patch, pimple patch, blemish patch, spot dots, dot patches etc.
Hydrocolloid patches are commercially available for medical purposes, so they are highly stable and are good for use on skin problems such as facial wounds or pimples.
Protect the wound from germs and contamination with Nurimedics products.
ISO13485 & ISO22176
Nurimedics has ISO13485 and ISO22716, which are guidelines for good manufacturing practice (GMP) in the cosmetics manufacturing industry.
ISO 13485 is an international standard that defines the requirements of the medical device industry. ISO 13485 is a management system that manufacturers must comply with from the production of medical devices to the post-production stages including disassembly and disposal. Through this, we produce and manage safe and high-quality medical products.
ISO 22716:2007 is a guideline for Good Manufacturing Practices (GMP) in the cosmetics manufacturing industry and is a requirement that companies that produce cosmetics must apply.
ISO 22716 consists of a total of 17 requirements, and these requirements are based on infrastructure management such as human resources, buildings, and equipment, and include manufacturing management from raw materials to finished products and process management from post-processing. Through this, we comply with legal requirements and at the same time secure reliability for safe manufacturing of cosmetics.
For USA, We have registered with FDA as a medical device and cosmetic facility, and we can proceed with customs clearance under DDP conditions and transportation to Amazon warehouses and desired locations.
Europe has completed CPNP registration for two types of Hydrocolloid patch products that we have.
United States: MoCRA-related facility registration has been completed and product registration is possible.
Europe: Documents can be submitted for CPNP registration.
