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Etnia Barcelona

by Etnia Eyewear Culture S.L 467 variants

Ref 5 CORAL 53O PUPKModel 4 SORA 53O BKHV

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number84357360ETNIABOPTICALFRRJ Basic UDI-DI 08447504030683UDI-DIDate21 Feb 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Montura Para Lente Graduada
Model / Reference
4 SORA 53O BKHV, 5 CORAL 53O PUPK
Primary DI / UDI-DI
08447504030683
Basic UDI-DI
84357360ETNIABOPTICALFRRJ
Direct Marketing DI
08447504030683
EMDN Code
Q02100299 Spectacle frames without lenses - other
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000035523

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Properties

Other properties (13)

  • Sterile: 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