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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 4 of 124| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Etnia Eyewear Culture | 4 SAPPHI 49O PGPT | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRUT17 54O HV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 EIXAMP 52S BEBR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 SENNA 55O PTBL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 VERA 48O HVRD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 ORWELL 48O 25 BK/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 AMMA 52O GR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 NOON 52O RDZE | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 NOVA 54O BX | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 ZAFRA 55S GR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 HALLE2 54O GRTQ | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 HANNAH 52O PU | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 VERA 50O BLPK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 STEP 45O BL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 TEIDE 51O PUHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 TULSA 56D BLHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BOB 46O BL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 ATIKUS 56S GD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 GRIMM 43S 00 FU/PK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 RONSAR 50O BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRUT16 51O BKCH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 EIXAMP 52D BKHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 HUXLE 52S 30 RDH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 POBLEN 50D BKHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 SIMB22 52D HVBE | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 MAMBO7 52S HVBL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 CARROL 49S 15 BK/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRUTA3 49O BL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 9 SILO 55O BEGM | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 MINNE2 55S HVGR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 PENTIK 52O WH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 MARCH 54O PG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRUTA7 48D CH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 BYTE 56O BL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 AZEEZA 52O BLZE | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 NERO 49O OG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 CESC 48O OGBK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 EXEC 57O OG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 CHURC 45S 15 BLH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRUT20 53O HV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 HUXLE 52S 30 BLH/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BIGS.L 52S BL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 IRVINE 52O PGPU | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 CONSTA 56O HVTQ | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 NARA22 48O GR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BUKOWS 56O GR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 IFAR21 54S BX | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 NISANTASI HVGD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 VERDI LEBE | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 OLMEDO 52O BK | FDA UDI | Class I | Active |
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