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Reading Glasses

by Wenzhou Huaxin Optical Co., Ltd 222 variants

Ref OM984 +1.50

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698017126AC7 Basic UDI-DIDate9 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
OM984 +1.50
Primary DI / UDI-DI
06980171261674
Basic UDI-DI
698017126AC7
EMDN Code
Q0210010102 Multifocal organic ophthalmic lenses (bifocal, trifocal)
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000055315
Authorised representative
WATERLILY MIRROR, UNIPESSOAL LDA PT-AR-000048588

Other devices from Wenzhou Huaxin Optical Co., Ltd

See all devices from Wenzhou Huaxin Optical 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