Polyco Healthline Group Limited

Polyco Healthline Group Limited specialises in disposable medical devices primarily for clinical and healthcare settings. Their portfolio includes nitrile gloves, such as the Jangro Blue PF range, which are designed for infection prevention. They also produce personal infection prevention products like the PIP line and hand hygiene solutions, including the ph Handsafe range. These products are developed to meet the hygiene and safety needs of healthcare professionals.

Polyco Healthline Group Limited is based in the United Kingdom (GB). As a UK-based manufacturer, their devices must comply with EU regulations if marketed within the European Union. Their products are classified under the EU Medical Device Regulation (MDR) and are listed in the EU’s centralised database, eudamed, which tracks medical devices authorised for use in the EU. This registry ensures transparency and traceability of their devices within the regulatory framework.

Polyco Healthline Group Limited’s devices are classified primarily as Class I under the EU Medical Device Regulation (MDR), which applies to low-risk products like disposable gloves and hand hygiene solutions. Some of their products fall under the In Vitro Diagnostic Medical Device (IVD) category, specifically as General IVD devices, due to their intended use in diagnostic or monitoring applications. Classification determines the regulatory requirements, with Class I devices generally requiring less stringent scrutiny than higher-risk categories.

Yes, Polyco Healthline Group Limited’s devices are listed in eudamed, the European Union’s centralised database for medical devices. This registry is maintained to ensure transparency and traceability of devices authorised for use within the EU. Listing in eudamed confirms that the manufacturer has complied with the necessary regulatory steps, such as conformity assessment and declaration of compliance, before placing their devices on the market. It also helps healthcare providers, regulators, and other stakeholders verify the legitimacy and regulatory status of the devices.