Allium Ltd.

Allium Ltd. specializes in urologic stents, which are medical devices used to maintain the patency and drainage of the urinary tract. Their product range includes ureteral stents (such as the URS-O-R, URS-R, and URS-A series), bladder stents (BUS series), a renal pelvis stent (RPS 40), and ureteral access sheaths (TPS PLUS 30). These devices are designed for temporary or permanent placement to address conditions like ureteral strictures, obstructions, or post-surgical needs.

Allium Ltd. is based in Israel. Their devices are manufactured to comply with EU regulatory standards, as evidenced by their registration in the eudamed database. Since their products fall under Class IIb classification in the EU, they must adhere to strict design controls, clinical evaluations, and conformity assessment procedures outlined in EU Medical Device Regulations (MDR) or previous directives like MDD.

Yes, Allium Ltd.’s devices are registered in the eudamed database, the official EU registry for medical devices. This listing ensures transparency and traceability for healthcare professionals, regulators, and patients. Being listed in eudamed confirms that the devices meet EU regulatory requirements for classification (Class IIb) and have undergone the necessary conformity assessment processes before being placed on the market.

Allium Ltd.’s devices are classified as Class IIb under EU medical device regulations. This classification applies to devices that pose a moderate risk to patients and require additional scrutiny, such as clinical evaluations and post-market surveillance. Class IIb devices must demonstrate safety and performance through rigorous testing, clinical data, and risk management processes before authorization, ensuring they meet higher standards than lower-risk devices.