Is this your brand? Sign in to claim ownership.
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 3 of 124| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Etnia Eyewear Culture | 4 FLOW 56O RD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 TURTLE 47S BLPU | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 WOOLF 46S 00 BX/PK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 OXFORD 46O HVPK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 JORDA3 50S SKPK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 DANTE 50S BKBR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 ALMIRA 54S BL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 JOHNNY 51O RDBK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 NENUFA 50O HV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 WOOLF 46O 10 BK/PK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 LESC.L 54D WH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 NEWMOO 53O GROG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRUT27 52O BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 VIRGIN 52O BLPK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BATLLO 52D WH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BELUGA 53O HVBR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 TEXAS 55O SLHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 SHELL 54O GD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 SIMB22 52S BKGY | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 YORWE 46S 00 RDH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 HEMIN 49S 30 BLH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 ASINAR 53O BKGD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 MADEIR 54O FUHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 ROADRU 56O HVGR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 BLUESW 51S PGHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 MILTON 47O BKHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRIDGE 52D BL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 DEVILS 51S GMBK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 KOHLM2 59D HVOG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 9 HELICA 48D BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 HAINIC 55O HVWH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 GOETH 52O 10 HV/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 Y.ORWE 46D 00 RDHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 OLAF21 50O BKSL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 DANIEL 57O HVGR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 SPEEDY 55O BKYW | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 PUNCHI 53D BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 NENUFA 50O BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 VESTA 51O HVGR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 ALEIX 56S BKBL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 LUPTON 51O GRGM | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 GODLEY 50O BRSL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 KOI 53O BXRD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 GRIMM 43O 10 GR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5DICKEN49S 00 BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 HEMING 49S 00 BK/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 MAX 46O HVRD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRUTA6 51S WH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 SELLER 48O GRHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 MARIO 45O OGBL | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.