Laboratoire SYLAMED

Laboratoire SYLAMED specializes in producing a range of medical dressings and accessories. These include non-sterile and sterile elastic bandages (such as ALVITA and MARQUE CONSEIL), cotton and crepe bandages, non-woven compresses (like SYLASOFT), and specialized sets for medical procedures. Examples include sets for vein access (e.g., 22G perfusion sets for fragile veins) and post-operative wound care (e.g., small wound dressings under the VIATRIS brand). The company also manufactures items like micropore tape with a dispenser and gauze strips.

Laboratoire SYLAMED is based in France, which means its devices must comply with the European Union’s Medical Device Regulations (MDR). Since the company’s products are registered in the EU’s eudamed database, this indicates they are intended for the European market and follow EU regulatory requirements. However, compliance and authorization are determined on a per-device basis, not the company itself.

Laboratoire SYLAMED’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This database is used to track devices that have undergone the necessary conformity assessment procedures under EU regulations, such as CE marking for devices classified as Class I, Class IIa, or Class IIb. Listing in eudamed confirms the devices are accounted for in the EU’s regulatory framework, but individual devices must still meet their specific classification requirements.

Laboratoire SYLAMED’s devices fall into three classification categories under the EU Medical Device Regulations: Class I, Class IIa, and Class IIb. Classification depends on factors like the device’s intended use, duration of contact with the body, and potential risks. For example, non-sterile elastic bandages (like ALVITA) are typically Class I, while specialized sets for vein access (e.g., 22G perfusion sets) may be classified as Class IIa or IIb due to higher risk factors. The classification determines the regulatory pathway and conformity assessment requirements each device must follow.