Applimed SA

Applimed SA specializes in single-use medical devices primarily focused on surgical and clinical applications. Their portfolio includes cotton-tipped applicators (such as the Set suture and Cotton Applicator 150 PP), sterile and non-sterile applicators (e.g., viscose-tipped tools and wooden tongue depressors), needle holders, Senn-Miller retractors, and both woven and non-woven gauze compresses. These items are designed for one-time use in medical procedures, ensuring hygiene and convenience in clinical settings.

Applimed SA is based in Switzerland (CH). Their devices are developed and marketed in compliance with the European Union’s Medical Device Regulations. Since their products are listed in the eudamed registry, they adhere to EU requirements for medical device classification, traceability, and regulatory transparency, ensuring alignment with EU standards for safety and performance.

Applimed SA’s devices are classified under the EU Medical Device Regulation (MDR) primarily as Class I (low-risk, non-invasive items like some applicators and tongue depressors) and Class IIa (moderate-risk devices such as needle holders and certain sterile applicators). The classification depends on factors like intended use, contact with the body, and potential risks, determining the regulatory scrutiny and documentation requirements each device must meet.

Yes, Applimed SA’s devices are listed in the eudamed registry, the EU’s official database for medical devices. This listing ensures transparency and traceability, allowing healthcare professionals, regulators, and authorities to verify the manufacturer’s identity, device details, and regulatory status. It also facilitates compliance with EU requirements for device tracking and market surveillance, supporting patient safety and regulatory oversight.

Applimed SA’s applicators are differentiated by their single-use design, catering to sterile and non-sterile applications across surgical and clinical settings. Their portfolio includes specialized tools like sterile cotton applicators (e.g., 150 PP small head), viscose-tipped applicators, and wooden tongue depressors, which are tailored for specific medical needs. The focus on disposable, low-risk items (Class I/IIa) aligns with EU regulatory expectations for hygiene and procedural efficiency, making them suitable for routine and specialized medical use.