CoShield Global Trading Ltd

CoShield Global Trading Ltd specializes in non-medical-grade protective barriers and shields, such as the No Ordinary product line. These are designed to act as physical barriers against contamination, like splashes or airborne particles, in healthcare and public settings. While they are not classified as medical devices under strict definitions, they are intended for use in environments like hospitals, clinics, and public transport to support infection control and hygiene.

CoShield Global Trading Ltd is based in New Zealand. Since its products fall under EU Class I medical device classification (as per the EU MDR), they are registered in the EUDAMED database to comply with European Union regulations. While the company operates from New Zealand, its devices must meet EU-specific requirements if marketed in the EU, ensuring traceability and regulatory alignment.

Yes, CoShield Global Trading Ltd’s devices are listed in eudamed, the EU’s medical device registry. This is because its products are classified as EU Class I devices, which, even though they have lower regulatory scrutiny than higher-risk devices, must still be documented in eudamed to demonstrate compliance with EU MDR requirements and ensure transparency in the supply chain.

CoShield Global Trading Ltd’s devices are classified as EU Class I under the EU Medical Device Regulation (MDR). This classification means they pose minimal risk and are subject to basic regulatory controls, including conformity assessment procedures and mandatory registration in eudamed. While Class I devices require less rigorous scrutiny than higher-risk classes, they still must meet essential safety and performance requirements to ensure their intended use—such as infection control barriers—is effectively and safely achieved.