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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 7 of 124| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Etnia Eyewear Culture | 5 RONSAR 50O HV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRUT15 51O BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BERTIN 51S HVZE | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 GRIMM 43D 30 HVPK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 PALS 51O OGBR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 HACELI 54D BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRUT14 49S OG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 SPEEDY 55O BKRD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 LORCA 53D BEGR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 PEARL2 48D HVTQ | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 PLA 47S YWHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 GRIMM 43O 10 HVPK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BIGSUR 52S HVGR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BATLLO 52D BE | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 LIN 57O GM | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 SITO 55O BKHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 CAROL 52S BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 PRATI2 47S PGHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 SACHS 55O PGHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 BRUT14 49D OG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 Y.ORWE 46D 10 BLHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 GUARDI 54O BL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 7 RUSINO 53D OG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 BUCHAN 50O GM | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 PARKGU 55O PGBK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 ORBIT 48O GR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 FROST 50S PGBR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 GRIMM 43D 10 FU | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 ENJOY 52O BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 KATHY 53O PKWH | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 CLASSE 50O BLOG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 9 DECK 54O RDPG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 WIMBLEDON BKRD | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5DICKEN49D 15 BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 MASS 51O BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 GOETH 52O 10 GR/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 CONNER 53O HVBL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 FLUX 51O CO | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 9 TORX 54D BK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 DICKEN 49S 25HV/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 MONTRA 53D YWHV | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 4 KEM 56O BLBK | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 FLUX 53O BX | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 PALA2 48S GYBR | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 LICEU 55D HVOG | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 PUIG 50O BLCL | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 BUCLE 48O GDCO | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 5 GRIMM 43D 00 YW | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 8 ORWELL 48O 25 HV/P | FDA UDI | Class I | Active |
| Etnia Eyewear Culture | 6 WAVE 53O PG | FDA UDI | Class I | Active |
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