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Turtle Reading Glasses

by Ispex Co., Ltd.

Ref 2.5 FUCHISA

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 Number471987914RD-01FR Basic UDI-DI 04719879140132UDI-DIDate25 Mar 2025RegisteredStatusActive

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  • Withdrawn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
2.5 FUCHISA
Primary DI / UDI-DI
04719879140132
Basic UDI-DI
471987914RD-01FR
EMDN Code
Q0210030102 Ready to wear plastic spectacles with organic lenses
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
TW-MF-000012095
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Ispex 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