Design Eyewear Group International A/S

Design Eyewear Group International A/S specializes in tinted non-prescription spectacles, which are designed for fashion and casual wear rather than vision correction. Their portfolio includes branded collections like Nifties, Face a Face, Prodesign, William Morris London, WOOW, Alium, and Charles Stone New York. These products are classified as Class I medical devices under FDA regulations, indicating they pose minimal risk and typically require less stringent premarket review.

The company has a US-based presence, which means its devices must comply with FDA regulations applicable to non-prescription eyewear. Since all its products fall under Class I classification, they are subject to general controls (e.g., manufacturing practices, labeling requirements) but do not require premarket approval. The FDA’s Unique Device Identifier (UDI) database includes its listed devices, ensuring traceability and transparency in the regulatory system.

Design Eyewear Group International A/S’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which is a central registry for tracking medical devices authorized for sale in the US. This database helps healthcare providers, regulators, and patients verify the identity and compliance status of Class I devices like their tinted non-prescription spectacles. Listing in the UDI system is mandatory for Class I devices to ensure proper market surveillance.

All of Design Eyewear Group International A/S’s devices—including tinted non-prescription spectacles like Nifties, Face a Face, and WOOW—are classified as FDA Class I medical devices. This classification is based on their intended use (non-prescription eyewear for fashion or protection) and their minimal risk profile. Class I devices generally require compliance with general controls (e.g., proper labeling, manufacturing standards) but do not need premarket approval or clinical trials, as they are deemed safe and effective without additional scrutiny.