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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 2 of 124| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Etnia Eyewear Culture | 4 CALVIN 54O PGBX | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 RSOUND 52D RD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 9 CADDY 51O BX | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 HUMPHR 52S GY | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 SABOYA 51O BLHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8435685015773 | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 DAUP22 50O BLPK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 3 SAN C. 55S BZGR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 CHR013 52O WHYW | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 SABOYA 51O GRPU | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 FONTAN 54S WHOG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 NAVAS 54S YW | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 CHR017 52S WH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 BRUT24 47O GRBL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5DICKEN49S 15 YWHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 BYTE 56O DGGR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 GRIMM 43O 25 GR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 CARROL 49S 20 BK/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 AVINY3 51D BEWH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 FREM17 SUN BKGD 56 | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 DICKEN 49S 10HV/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 IMEDES 50D GDHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 FROST 50S GDGR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 BRERA2 56O GDBK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 HUXLE 52S 10 YWH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 JAUME 52O BKYW | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 LICEU 55S BKBR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 RENNER 51O TQOG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 ASTRO 47O BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 CARD 43O OGPU | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 MAGNET 55S BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 AGAR 52O OG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 WOOLF 46S 15 HV/PK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 SASTRE 53S HVBK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BETTE 53D BKPU | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 CHURC 45S 20 YWH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 MAATHA 51O PK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5DICKEN49O 10 HV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 SELIGM 53O BKOG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 TRINIT 62S BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 BOURBO 49O BLPG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 FENTON 60O PTSL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 LIGH12 48O COSK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 ESTER 48S GRBR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 CARR.C 50S 10 SL/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5DICKEN49O 15 BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 Y.ORWE 46O 00 BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 SENECA BRGR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 MATEE 51O BR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BAVIER 54O BLPK | FDA UDI | Class I | Active |
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