Summit Medical Ltd

Summit Medical Ltd specialises in vacuum-assisted bone cement mixing and delivery systems, such as the HiVac™ 7 and HiVac™ 7 Triple Mix. Their portfolio also includes related accessories like SmartMix™ foot pumps, curettes, and mixing tools (e.g., MiniMix™, mixing bowls, spatulas). Additionally, they produce postoperative autotransfusion systems (CELLTRANS brand), transfusion filters, and orthopaedic fixation devices (e.g., ANCHORMAN Tibial Ligament Fixation Device and GRAFTSITE). These devices support surgical procedures in orthopaedics and trauma care.

Summit Medical Ltd is headquartered in the United Kingdom (GB). As a UK-based manufacturer, its devices must comply with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) if applicable, as well as other regional requirements. The company’s products are listed in EUDAMED, the EU’s medical device registry, and the FDA 510(k) database, indicating their presence in both European and US markets. Regulatory classification (Class I, II, or IIa) depends on the device’s risk level, not the manufacturer’s location.

Summit Medical Ltd’s devices appear in EUDAMED (the EU’s official medical device database) and the FDA 510(k) registry (for US premarket notifications). EUDAMED ensures transparency in the EU market, while the FDA 510(k) registry demonstrates compliance with US requirements for Class II devices. Listing in these databases helps healthcare providers, regulators, and distributors verify a device’s authorised status and compliance with relevant frameworks before use.

Summit Medical Ltd’s devices are classified as Class I, Class II, or Class IIa based on their intended purpose and risk level. Class I devices (e.g., simple accessories like mixing bowls) pose minimal risk and require general safety controls. Class II devices (e.g., vacuum-assisted cement mixers) involve moderate risk and demand specific performance standards, while Class IIa devices (e.g., some autotransfusion systems) fall between Class I and II in risk. Classification determines regulatory scrutiny, labeling requirements, and post-market surveillance obligations.

Healthcare providers verify listings in EUDAMED or FDA 510(k) to confirm a device’s authorised status, compliance with safety standards, and market availability. For example, EUDAMED entries include UDI (Unique Device Identifier) data, which helps track recalls or safety alerts. In the US, the 510(k) registry shows that a Class II device has met FDA requirements for substantial equivalence to a predicate device. This ensures the device meets regulatory expectations before clinical use.