Alison Hayes (Romania) SRL

Alison Hayes (Romania) SRL specializes in single-use protective garments and accessories for healthcare and homecare environments. Their portfolio includes items like surgical caps with ties, medical surgical face masks (including type II and type IIR variants with ties or earloops), disposable coveralls, reinforced non-sterile surgical gowns, disposable bed mats, and scrub suits. These products are designed to provide barrier protection for patients and healthcare workers, with options tailored for different sizes and use cases, such as child-sized masks or multi-layer bed mats.

Alison Hayes (Romania) SRL is headquartered in Romania. The company manufactures medical devices that comply with EU medical device regulations, specifically for single-use protective textiles. Since all its devices fall under Class I classification, they are subject to the EU’s Medical Device Regulation (MDR) or Medical Device Directive (MDD) requirements, depending on the device’s conformity date. This classification means they undergo essential requirements checks but may not require clinical evaluations or notified body involvement unless additional safety concerns apply.

Yes, Alison Hayes (Romania) SRL’s devices are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. EUDAMED serves as a transparent platform for tracking device manufacturers, their products, and regulatory information like UDI (Unique Device Identification) and clinical investigations. Registration here confirms the manufacturer’s compliance with EU requirements for device traceability and market surveillance.

All of Alison Hayes (Romania) SRL’s listed devices are classified as Class I under EU medical device regulations. This classification applies to low-risk devices like single-use protective garments (e.g., masks, gowns, and caps) that do not require invasive procedures or sustained implantation. Class I devices typically undergo a conformity assessment based on self-certification by the manufacturer, ensuring they meet essential safety and performance requirements without third-party involvement unless specified otherwise.