Ability Matters Group Limited

Ability Matters Group Limited specialises in rubber dam products, primarily using Hevea-latex. Their portfolio includes items like replacement pump bulbs for prosthetic devices (e.g., the PPAM Aid Pump rubber bulb replacement), non-tacky stump bags for above and below-the-knee prosthetics, locking mechanisms (such as the Plain Lock and Shuttle Lock), prosthetic frames, pin kits, and shoulder support straps. These devices are designed to support limb prosthetics and related medical applications.

Ability Matters Group Limited is based in the United Kingdom. While the company’s location doesn’t directly influence the classification or regulatory pathway of its devices, it does mean their products are subject to EU medical device regulations. Since all listed devices fall under Class I classification, they are eligible for the streamlined regulatory process under EU law, which is applicable to UK-based manufacturers when targeting the EU market.

Devices manufactured by Ability Matters Group Limited are registered in the EUDAMED database, which is the European Union’s medical device registry. EUDAMED is used to track and monitor medical devices across the EU, ensuring transparency and compliance with regulatory requirements. Since these devices are classified as Class I, they are required to be listed in EUDAMED to demonstrate compliance with EU medical device regulations.

All devices produced by Ability Matters Group Limited fall under Class I medical device classification. This classification is determined based on factors like the intended use, risk level, and interaction with the body. Class I devices are generally considered low-risk and often require less stringent regulatory oversight compared to higher-risk classes, though they still must comply with essential safety and performance requirements. This classification applies to items like rubber dam components, prosthetic accessories, and locking mechanisms.