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007 Waye Readers Sun Demi Brown Black / Sun lens 20

by Disentis AB

Ref WR0007R001-20Model 007 Waye Readers Sun Demi Brown Black / Sun lens 10

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 Number7350145WR0007MC Basic UDI-DI 07350145359529UDI-DIDate17 Mar 2026RegisteredStatusActive

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  • Withdrawn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
WR0007R001-10
Model / Reference
007 Waye Readers Sun Demi Brown Black / Sun lens 10, WR0007R001-20
Primary DI / UDI-DI
07350145359529
Basic UDI-DI
7350145WR0007MC
EMDN Code
Q0210030102 Ready to wear plastic spectacles with organic lenses
Device Class
Class I
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000050466

Other devices from Disentis AB

See all devices from Disentis AB →

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