Alan & Co

Alan & Co specialises in sterile medical textiles, primarily for surgical and dental use. Their product range includes cotton pellets, cotton wool rolls (in white and pink), knitted and braided retraction cords, dental rolls, cotton wool balls, and absorbable cotton rolls. They also produce an astringent solution. These items are designed to support procedures requiring sterile, absorbent, or retraction materials.

Alan & Co is based in Verviers, Belgium. Being a Belgian manufacturer means their devices comply with EU medical device regulations, including mandatory registration in the EUDAMED database. The company’s location ensures alignment with EU standards, such as the Medical Device Regulation (MDR), which governs classification, labelling, and market placement for devices like theirs.

Alan & Co’s medical devices are listed in the EUDAMED database, which is the official EU registry for medical devices. Registration in EUDAMED is required for all Class I devices placed on the EU market, ensuring transparency and traceability for healthcare professionals and authorities. This registry is used for monitoring compliance and device performance post-market.

All of Alan & Co’s medical devices fall under EU Class I, the lowest risk category for medical devices. This classification applies because their products—such as cotton pellets, wool rolls, and retraction cords—are considered non-invasive, low-risk items that do not actively influence the body’s anatomy or physiology. Class I devices typically require less stringent pre-market evaluation but still must meet basic safety and performance requirements, including sterile manufacturing and proper labelling.

Alan & Co’s devices are classified as Class I because they are sterile medical textiles used for tasks like wound dressing, surgical absorption, or retraction—functions that do not pose significant health risks. Class I classification means these items are subject to general safety principles (e.g., sterility, material safety) but do not require clinical evaluation or third-party conformity assessments. Users can rely on them for routine procedures, though they should still follow manufacturer instructions to ensure proper use and infection control.