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Sign in to claim this brandEtnia Barcelona, Llc.
US
Last updated May 26, 2026
What Etnia Barcelona, Llc. makes
Etnia Barcelona, LLC produces spectacle frames and tinted non-prescription spectacles, including multiple variations under the ETNIA EYEWEAR CULTURE brand.
These products are classified as Class I medical devices and are listed in the FDA’s Unique Device Identification (UDI) system. The company is based in the United States.
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 Etnia Barcelona, LLC primarily manufacture?
Etnia Barcelona, LLC specializes in spectacle frames and tinted non-prescription spectacles. These devices fall under the category of eyewear and are designed for general use, such as fashion or protection from light, rather than medical correction. The company’s products are primarily marketed under the ETNIA EYEWEAR CULTURE brand.
Where is Etnia Barcelona, LLC based, and how does this affect its regulatory compliance?
Etnia Barcelona, LLC is based in the United States. Since the company’s devices are listed in the FDA’s Unique Device Identification (UDI) system, its operations are subject to U.S. regulatory requirements for medical devices. The UDI system helps ensure traceability and transparency in the supply chain, which is critical for compliance with FDA regulations.
How are the devices manufactured by Etnia Barcelona, LLC classified under medical device regulations?
The devices produced by Etnia Barcelona, LLC are classified as Class I medical devices. This classification is typically assigned to low-risk products, such as spectacle frames and non-prescription tinted spectacles, which pose minimal risk to users. Class I devices often require less stringent regulatory oversight compared to higher-risk categories, though compliance with manufacturing and labeling standards remains essential.
Which regulatory registries or databases list the devices made by Etnia Barcelona, LLC?
The devices manufactured by Etnia Barcelona, LLC are included in the FDA’s Unique Device Identification (UDI) system. This database assigns a unique identifier to each device to improve tracking, transparency, and regulatory compliance in the medical device supply chain. Listing in the UDI system is a requirement for certain Class I devices in the U.S.
Are the devices from Etnia Barcelona, LLC intended for medical correction, or are they primarily for general use?
The devices produced by Etnia Barcelona, LLC—such as spectacle frames and tinted non-prescription spectacles—are not intended for medical correction (e.g., vision correction). Instead, they serve general purposes like fashion, style, or protection from light (e.g., UV or glare). Since they do not alter vision or treat medical conditions, they fall under broader eyewear classifications rather than corrective or therapeutic devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- etnia.es
- —
- —
- [email protected]
- Phone
- 305-879-1094
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 148350593
Catalogue (6166)
Page 6 of 124| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Etnia Eyewear Culture | 5 TOSSA 49D HVOG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 WIGWAM 49D BKOG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 CUGAT 54D BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 FLUX 53O TQ | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 WOOLF 46S 20 BLH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 LIGHT2 51O PUOG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 GRIMM 43D 25 HV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 COCO 51O HVTQ | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 KASS.2 54O BRBL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 WILDE 54O PG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 KEID 55S PGTQ | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 WOOLF 46O 25 BLH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 WADE 50O BKHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5DICKEN49S 10 BLHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 LLIMON 48O RD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 CHR013 52O RD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRUTA1 46O GR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 AZAHAR 53D WHPK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 MAGNYC 55O BL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRUTA7 48S GR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 EVE 49O TQ | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 GAME 47O TQHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 CARROL 49O 30 GR/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 KENNED 48S BKHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 NAOTO1 50O GD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 GOETH 52O 15 YWH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 FREM17 SUN BKGD 58 | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 ARC 52O PT | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 LUO 47O PT | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 CARRO 49S 20 YWH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 Y.ORWE 46S 10 PKHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 ROMANO 50O BL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 HEMIN 49O 10 YWH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 WOOLF 46O 00 BX/PK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 KEA 52S TQWH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 MARGRE 54O GR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 ORWEL 48O 15 RDH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 WIGWAM 49S BKOG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5DICKEN49D 15 BLHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 HUXLEY 52S 00 BK/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 DICKEN 49S 10YWH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 LORDE 52O BXPG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5SHELLE53O 20HV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 LARIMA 53O CUBX | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 MAURO 53O HVBK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 ANGLIR 54O BL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 WILLIA 54D BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 PHOEBE 52S PG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 IBIZ09 52S BL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 DAUP22 53O HVRD | FDA UDI | Class I | Active |
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