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Sostrene Reader

by Wenzhou Sunrise Industrial and Trading Co., Ltd 46 variants

Ref RDR04837-003

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697767960REGLY4 Basic UDI-DI 06977679600197UDI-DIDate26 Jul 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  • Withdrawn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
Reading glasses
Model / Reference
RDR04837-003
Primary DI / UDI-DI
06977679600197
Basic UDI-DI
697767960REGLY4
Direct Marketing DI
06977679600197
EMDN Code
Q0210030102 Ready to wear plastic spectacles with organic lenses
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000043059
Authorised representative
Humiss Beratung GmbH DE-AR-000023447

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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