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Sign in to claim this brandDesign Eyewear Group International A/S
US
Last updated May 23, 2026
What Design Eyewear Group International A/S makes
Design Eyewear Group International A/S manufactures tinted non-prescription spectacles, including branded and designer collections such as Nifties, Face a Face, Prodesign, and William Morris London. Their portfolio also includes eyewear under the WOOW, Alium, and Charles Stone New York labels, catering to fashion-forward and casual wear.
All products fall under FDA Class I medical device classification and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates with a US-based presence, adhering to regulatory requirements for non-prescription eyewear.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Design Eyewear Group International A/S primarily manufacture?
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.
Where is Design Eyewear Group International A/S based, and how does this affect its regulatory compliance?
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.
Which regulatory registries or databases list Design Eyewear Group International A/S’s devices?
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.
How are Design Eyewear Group International A/S’s devices classified under FDA regulations?
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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 305847477
Catalogue (1199)
Page 3 of 24| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Prodesign | 81274921 | FDA UDI | Class I | Active |
| Charles Stone New York | CSNY40027C2 | FDA UDI | Class I | Active |
| Face a Face | FFWATTS1/100 | FDA UDI | Class I | Active |
| Woow | WWSUPERBIEN2/0338 | FDA UDI | Class I | Active |
| Woow | WWSUPERLOOP1/5465 | FDA UDI | Class I | Active |
| Face a Face | FFAALTO1/012 | FDA UDI | Class I | Active |
| Face a Face | FFECLIPS1/2150 | FDA UDI | Class I | Active |
| William Morris London | WMSU10013C2 | FDA UDI | Class I | Active |
| Woow | WWSUPERVIVE1/0110 | FDA UDI | Class I | Active |
| Face a Face | FFGIOCO2/487 | FDA UDI | Class I | Active |
| Face a Face | FFVERSO2/2063 | FDA UDI | Class I | Active |
| Prodesign | PDCONICAL3S/6032 | FDA UDI | Class I | Active |
| Face a Face | FFECLIPS1/0078 | FDA UDI | Class I | Active |
| Face a Face | FFSTEAM2/2150 | FDA UDI | Class I | Active |
| Face a Face | FFBOCCAPIXIES2/1946 | FDA UDI | Class I | Active |
| Charles Stone New York | CSNY40026C2 | FDA UDI | Class I | Active |
| Face a Face | FFGIOCO2/008 | FDA UDI | Class I | Active |
| Woow | WWSUPERJET2/901 | FDA UDI | Class I | Active |
| Woow | WWBOLLYWOOL4/3006 | FDA UDI | Class I | Active |
| Woow | WWSUPERJOLIE1/4930 | FDA UDI | Class I | Active |
| Face a Face | FFAALTO2/0078 | FDA UDI | Class I | Active |
| Prodesign | 86735524 | FDA UDI | Class I | Active |
| Nifties | NI98439034 | FDA UDI | Class I | Active |
| Woow | WWSUPEREDGY2/0382 | FDA UDI | Class I | Active |
| Prodesign | PDEXTRUSION2S/9525 | FDA UDI | Class I | Active |
| Prodesign | PDGAILTWELVE/9031 | FDA UDI | Class I | Active |
| Inface | IF98675024 | FDA UDI | Class I | Active |
| Face a Face | FFCINEMA2/6154 | FDA UDI | Class I | Active |
| Face a Face | FFECLIPS2/6092 | FDA UDI | Class I | Active |
| Prodesign | 86763525 | FDA UDI | Class I | Active |
| Woow | WWSUPERVIVE2/053 | FDA UDI | Class I | Active |
| Prodesign | PDEXTRUSION2S/6525 | FDA UDI | Class I | Active |
| William Morris London | WMSU10069C1 | FDA UDI | Class I | Active |
| Charles Stone New York | CSNY40027C1 | FDA UDI | Class I | Active |
| Nifties | NI98391445 | FDA UDI | Class I | Active |
| Face a Face | FFBOCCAPIXIES1/1102 | FDA UDI | Class I | Active |
| Face a Face | FFECLIPS2/100 | FDA UDI | Class I | Active |
| Woow | WWSUPERMEC2/3035 | FDA UDI | Class I | Active |
| Woow | WWSUPERBOLD1/1161 | FDA UDI | Class I | Active |
| Woow | WWSUPERROCKET2/0179 | FDA UDI | Class I | Active |
| Woow | WWSUPERBUSY1/0131 | FDA UDI | Class I | Active |
| Prodesign | 86789535 | FDA UDI | Class I | Active |
| Prodesign | 86744035 | FDA UDI | Class I | Active |
| Face a Face | FFTILDE2/0384 | FDA UDI | Class I | Active |
| Woow | WWSUPERSYMPA2/0091 | FDA UDI | Class I | Active |
| Nifties | NI98626032 | FDA UDI | Class I | Active |
| Woow | WWSUPERJOLIE2/100 | FDA UDI | Class I | Active |
| Nifties | NI98404344 | FDA UDI | Class I | Active |
| Woow | WWSUPERWAVY1/0562 | FDA UDI | Class I | Active |
| Woow | WWSHOWOFFSUN3/9404 | FDA UDI | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Design Eyewear Group International A/S Tranbjerg Midtjylland · DK FEI 3013363696