Standards

Regulation and Applicable Standards

At Icemedics, we provide our customers with the best personalized advice, and our goal is to develop quality products in terms of design, manufacturing, and required regulations.

When we talk about quality in our gloves, we don’t just refer to regulations and certifications, nor to their weight or thickness, but rather to the entire manufacturing process, controlling their compositions to minimize skin irritation, ensure the best adaptability, and maximize sensitivity.

The world of gloves is regulated and subject to mandatory regulations depending on their use. All our gloves have the European Declaration of Conformity in accordance with Regulation (EU) 2016/425.

Icemedics is included in the Register of Responsible Persons for Placing Medical Devices on the Market (RPS) of the Spanish Agency of Medicines and Medical Devices (AEMPS), with the code RPS/778/2023.

RPS/778/2023

Icemedics is an authorized legal representative in Europe, allowing us to offer the highest guarantee to our customers.

SRN: ES-AR-000035147

https://ec.europa.eu/tools/eudamed/#/screen/search-eo

Icemedics holds the license for the importation of medical products granted by the Spanish Agency of Medicines and Medical Devices, under registration number 6911-PS.

6911-PS