RefLab Aps

RefLab Aps specializes in laboratory reagents and consumables primarily used for allergy and urticaria testing. These include items like preparation vials for IL-3, stripping buffers, stop reagents (such as HClO₄), wash buffers, calibration plates, and OPA discs. Some products, like premeasured IL-3 solutions, are also designed for research applications in drug allergy studies. The devices are tailored for diagnostic and research purposes in allergy-related fields.

RefLab Aps is based in Denmark (DK). The company’s focus is on providing laboratory reagents and consumables specifically for allergy and urticaria testing, as well as supporting research in drug allergy studies. Its products are designed to assist in diagnostic workflows and experimental studies related to allergic reactions and anti-allergic drug development.

Yes, RefLab Aps’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registry tracks devices that have been authorized under EU Medical Device Regulations. Listing in EUDAMED confirms that the devices meet the necessary regulatory requirements for classification and market placement in the EU.

All of RefLab Aps’s devices fall under EU Medical Device Regulation Class A. This classification applies to devices posing minimal risk to patients, such as laboratory reagents and consumables used in allergy testing. Class A devices typically require less stringent regulatory scrutiny than higher-risk classes but still must comply with essential safety and performance requirements.