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H2O

by Wenzhou Sunrise Industrial and Trading Co., Ltd 7 variants

Ref RDR05175, RDS00300 +3.0, RDR05361 +1.5, RDR05361 +2.0, RDR05163 +2.5, RDR05163, RDR05361 +2.5

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 Number697767960REGLY4 Basic UDI-DI Date26 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  • Withdrawn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
RDR05175, RDS00300 +3.0, RDR05361 +1.5, RDR05361 +2.0, RDR05163 +2.5, RDR05163, RDR05361 +2.5
Primary DI / UDI-DI
06977679604263, 06977679604355, 06977679604362, 06977679604256, 06977679604379, 06977679604300, 06977679604287, 06977679604386, 06977679604249
Basic UDI-DI
697767960REGLY4
Direct Marketing DI
06977679604263
06977679604355
06977679604362
06977679604256
06977679604379
06977679604300
06977679604287
06977679604386
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

Other devices from Wenzhou Sunrise Industrial and Trading Co., Ltd

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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