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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 5 of 124| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Etnia Eyewear Culture | 4 BAUDEL 56O GD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 SANT22 53D HVBE | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 SUSSEX 53O GRHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 LAUGH 49O YW | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 GIMFER 55O HV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 VICE22 51O HVBL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 KREUZ2 47O TQHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 LARIMA 55O GDBL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 HARRY 46O BLSL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 OLLER 49S OG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 MAZE 45O OG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 CHARTR 55O RDGY | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRUT18 47O RDCH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 CELAYA 53O BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 DEVILS 51D GMBK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 GRIMM 43S 00 GR/PK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 ORBIT 48O OGTQ | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 BRUT10 46O TQ | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRUTA4 45O GR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 SILVI 52O BXSK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 ZOID 49O BLOG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 Y.ORWE 46S 00 YWHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 MUNG.L 57S WH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 HEMIN 49O 25 BLH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 MUNGER 57D BKHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 KASS.2 54O RD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 GILBER 57O GRGM | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 ARIA 53O TQSK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 LIGHT2 51O BL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 LORCA 53S BKBL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 ALAIOR 56S GMBX | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 ASTRO 47O GY | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 HEMING 49O 20 BK/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 RIMBAU 51O BLHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 AUDREY 53D HV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 FONTAN 54D HVWH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 9 RENEE 52O BKGM | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 ROMANO 50O HVWH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 SCHNEI 49O SLHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 DAKOTA 52O BKGR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 VECTOR 48O RD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 SUZUKA 54O BKBL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BELICE 49S YWHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 HANNAH 52O HVBL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 BRNO GYBL 56 | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 PECOS 57S BKBR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 DAVAO 53S GYBL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 IGGI 53O BL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 9 NAOS 50O CLGD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 9 CAPLET 56O CLBL | FDA UDI | Class I | Active |
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