Skip to content

Etnia Barcelona

by Etnia Eyewear Culture S.L 1,000+ variants

Ref 5 ROCCO 52O HVGRModel 4 SORA 53O BKHV

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Overview

The ETNIA BARCELONA medical device is a high-end optical solution designed for near-patient testing and professional use. It features advanced technology, precise measurement, and sleek design. For detailed information on its functionality, compliance, and regulatory status, please refer to the provided documentation.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08435736081672 UDI-DI Date24 Jan 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number84357360ETNIABOPTICALFRRJ Basic UDI-DI 08435736081672UDI-DIDate21 Feb 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Etnia Barcelona EUDAMED
Etnia Eyewear Culture GUDID
Generic Name
Spectacle frame
Device Name
Montura Para Lente Graduada
Model / Reference
4 SORA 53O BKHV, 5 ROCCO 52O HVGR
Primary DI / UDI-DI
08435736081672
Basic UDI-DI
84357360ETNIABOPTICALFRRJ
Direct Marketing DI
08435736081672
FDA Product Code
HQZ
EMDN Code
Q02100299 Spectacle frames without lenses - other
GMDN Term
Spectacle frame
Device Class
Class I
Regulation Number
886.5842
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
ES-MF-000035523

Other devices from Etnia Eyewear Culture S.L

See all devices from Etnia Eyewear Culture S.L →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No