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Metal Half rim Optical Frames

by Wenzhou Hivision Eyewear Co., Ltd 5 variants

Ref GM3003 GM#864, GM3003 GM#863

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697154133metalhalfrimFM Basic UDI-DIDate1 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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

Trade Name
Metal Half rim Optical Frames
Half Metal rim Optical Frames
Model / Reference
GM3003 GM#864, GM3003 GM#863
Primary DI / UDI-DI
06971541337600, 06971541337594
Basic UDI-DI
697154133metalhalfrimFM
Direct Marketing DI
06971541337600
06971541337594
EMDN Code
Q0210030101 Ready to wear metal 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

See all devices from Wenzhou Hivision Eyewear Co., Ltd →

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