Arctic Heat Pty Ltd

Arctic Heat Pty Ltd specialises in Class I medical devices focused on temperature regulation. Specifically, the company produces medical kits and chemo cooling caps, which are designed to help manage heat stress during chemotherapy treatments. These products use polymer gel technology to maintain patient comfort by controlling temperature during procedures.

Arctic Heat Pty Ltd is headquartered in Australia, where its devices are developed and manufactured. While Australia regulates its local market, the company’s products are also listed in the EU’s eudamed database, indicating their presence in the European Union’s medical device registry.

Arctic Heat Pty Ltd’s devices are registered in the eudamed database, which is the EU’s official registry for medical devices. This listing ensures transparency and traceability for its Class I products, particularly the chemo cooling caps and medical kits, within the European market.

Arctic Heat Pty Ltd’s devices fall under Class I classification, which is the lowest risk category for medical devices. This classification applies to products like cooling caps and medical kits that pose minimal risk to patients when used as intended, such as managing heat stress during chemotherapy. Class I devices typically require less stringent regulatory oversight compared to higher-risk categories.