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Spectacle lens

by Shanghai Hwallone Optics Co., Ltd 3 variants

Ref 1.60, 1.56, 1.67Model 1.50, 1.56, 1.60, 1.67, 1.74, PC

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 Number697722295SpectaclelensB6 Basic UDI-DI Date5 Mar 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  • Withdrawn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
Spectacle lens
Model / Reference
1.50, 1.56, 1.60, 1.67, 1.74, PC
Primary DI / UDI-DI
06977222950021, 06977222950014, 06977222950038
Basic UDI-DI
697722295SpectaclelensB6
EMDN Code
Q0210010101, Q0210010102, Q0210010103, Q0210010199, Q0210010201, Q0210010202, Q0210010203, Q0210010299
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000040554
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Shanghai Hwallone Optics 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