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Plastic full rim Optical Frames

by Wenzhou Hivision Eyewear Co., Ltd China EUDAMED

Ref FS0018 C1

EMDN Q0210030102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697154133plasticfullrimPK Basic UDI-DIDate12 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
FS0018 C1
Primary DI / UDI-DI
06971541338157
Basic UDI-DI
697154133plasticfullrimPK
Direct Marketing DI
06971541338157
EMDN Code
Q0210030102 Ready to wear plastic spectacles with organic lenses
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000021929
Authorised representative
MYM SOPORTE TECNICO Y DE CALIDAD, S.L. ES-AR-000017300

Other devices from Wenzhou Hivision Eyewear Co., Ltd

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Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 269bd7e7-bc92-4273-b36d-98d22eeb9db7 61 fields · synced 22 Oct 2026