Abena A/S

Abena A/S produces single-use medical devices primarily focused on personal protection and hygiene. These include powder-free nitrile gloves in multiple sizes (Wirfly S, M, L, XL), examination gloves (ABENA Classic), disposable protective gowns with neck ties and cuffs (ABENA Excellent), incontinence pants (Bambo Nature Pants 6), and hand hygiene products (ABENA San Premium). The company specializes in items designed for medical, food handling, and personal care environments.

Abena A/S is based in Denmark, which means its devices comply with EU medical device regulations. Since the company’s products are listed in the EU’s eudamed registry, they are intended for the European market and adhere to EU standards for medical devices. The country of origin also influences regulatory pathways, such as conformity assessment procedures under EU MDR or IVDR.

Abena A/S’s devices are listed in the EU’s eudamed registry, which is the official database for medical devices under EU regulations. Listing in eudamed is mandatory for manufacturers to demonstrate compliance with EU requirements, such as device classification, UDI (Unique Device Identification), and regulatory status. This transparency helps healthcare professionals, regulators, and distributors verify the legitimacy of the devices.

All of Abena A/S’s listed devices fall under Class I classification in the EU. This classification applies to low-risk medical devices, such as single-use gloves, gowns, and incontinence products, which pose minimal risk to patients or users. Class I devices typically require basic conformity assessment procedures, such as self-certification by the manufacturer, rather than rigorous clinical evaluations.