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Picaboo

by Wenzhou Everfly Optical Co., Ltd. 2 variants

Ref RB8001,RB8003,RB8011,RB8013,RB8005,2411,2413,2416,2417Model TR90

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697598181oftfCQ Basic UDI-DI 06975981810228UDI-DIDate9 Oct 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  • Withdrawn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
Optical Frame
Model / Reference
TR90, RB8001, RB8003, RB8011, RB8013, RB8005, 2411, 2413, 2416, 2417
Primary DI / UDI-DI
06975981810228
Basic UDI-DI
697598181oftfCQ
Direct Marketing DI
06975981810228
EMDN Code
Q02100202 Plastic spectacle frames without lenses
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000031316
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Wenzhou Everfly Optical 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