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Rosa Brillo - Rosa Brillo

by Wenzhou Changhui International Trade Co., Ltd. 5 variants

Ref CRF-RED-200 Rosa BrilloModel REDONDA

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 Number697594490REDONDAAY Basic UDI-DI 06975944900461UDI-DIDate10 Oct 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  • Withdrawn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
Rosa Brillo;Tortoise Mate;Transparente Brillo
Model / Reference
REDONDA, CRF-RED-200 Rosa Brillo
Primary DI / UDI-DI
06975944900461
Basic UDI-DI
697594490REDONDAAY
Direct Marketing DI
06975944900461
EMDN Code
Q0210010102 Multifocal organic ophthalmic lenses (bifocal, trifocal)
Models / Variants
Rosa Brillo
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000031322
Authorised representative
Humiss Beratung GmbH DE-AR-000023447

Other devices from Wenzhou Changhui International Trade Co., Ltd.

See all devices from Wenzhou Changhui International Trade 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