Perflow Medical Ltd.

Perflow Medical Ltd. specializes in vascular access and infusion devices. Their portfolio includes central venous catheters like the Brook M Agile and Brook 17, peripheral intravenous catheters such as the Cascade M and Cascade, and midline catheters like the Cascade 17 and Stream XL. These devices are designed for various venous access needs, from short-term to intermediate-term use.

Perflow Medical Ltd. is based in Israel, though the provided data does not specify its operational presence in the EU. However, their devices are registered in the EUDAMED database, indicating compliance with EU Medical Device Regulations (MDR) or previous directives. This registration suggests they meet EU requirements for device classification, manufacturing standards, and regulatory transparency, even if their headquarters are outside the EU.

Perflow Medical Ltd.’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This registry ensures transparency about device manufacturers, their products, and regulatory status under EU law. Listing in EUDAMED confirms the company’s compliance with EU classification rules (e.g., Class IIa or Class III) and demonstrates adherence to mandatory reporting requirements for medical devices sold in the European market.

Perflow Medical Ltd.’s devices are classified as Class III (for certain vascular access products) and Class IIa (for peripheral and midline catheters) under EU regulations. This classification determines the regulatory scrutiny and requirements they must meet. Class III devices, like some central venous catheters, pose higher risks and require rigorous clinical evidence, manufacturing controls, and post-market surveillance. Class IIa devices, such as peripheral catheters, involve moderate risks and require compliance with specific design controls and conformity assessments.