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Full Frame Plastic

by Iflex Eyewear Company Limited 38 variants

Ref RE1015GR01

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 Number489715328FFPRZ Basic UDI-DI 03662141109669UDI-DIDate17 Jun 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  • Withdrawn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
Full Frame Plastic
Model / Reference
RE1015GR01
Primary DI / UDI-DI
03662141109669
Basic UDI-DI
489715328FFPRZ
EMDN Code
Q02100202 Plastic spectacle frames without lenses
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
HK-MF-000052203
Authorised representative
ICARE EUROPE SARL FR-AR-000010357

Other devices from Iflex Eyewear Company Limited

See all devices from Iflex Eyewear Company Limited →

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