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Spectacle Frame

by Kelfred Optical Limited EUDAMED

Active European Union

Ref HIKARI-BLACK-GREY, ARCHIE-SILVER-CRYSTAL, DAWSON-BLACK-BLACK, ARBOR-BLACK-BLACK, R14K32-C4, CAMPBELL-BROWN HAVANA-SILVER, HIKARI-WHITE-BROWN, FLORIAN-BLACK-BLACK, LANE-BLACK-BLACK, HIKARI-SILVER-CRISTAL, ARCHIE-BLACK-BLACKModel ALJ16028 ALJ16029 ALJ16030 ALJ16031 ALJ16032 ALJ16033 ALJ16034 ALJ16035 ALJ16036 ALJ16037 ALJ16038 ALJ16039 ALJ16040 ALJ16041 ALJ16042 ALJ16043 ALJ16044 ALJ16045 etc

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number489705918OpticalframeD3 Basic UDI-DIDate2 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Optical Frame
Model / Reference
ALJ16028 ALJ16029 ALJ16030 ALJ16031 ALJ16032 ALJ16033 ALJ16034 ALJ16035 ALJ16036 ALJ16037 ALJ16038 ALJ16039 ALJ16040 ALJ16041 ALJ16042 ALJ16043 ALJ16044 ALJ16045 etc, HIKARI-BLACK-GREY, ARCHIE-SILVER-CRYSTAL, DAWSON-BLACK-BLACK, ARBOR-BLACK-BLACK, R14K32-C4, CAMPBELL-BROWN HAVANA-SILVER, HIKARI-WHITE-BROWN, FLORIAN-BLACK-BLACK, LANE-BLACK-BLACK, HIKARI-SILVER-CRISTAL, ARCHIE-BLACK-BLACK
Primary DI / UDI-DI
04895238503067, 04895238503371, 04895238503463, 04895238503340, 04895238503029, 04895238503456, 04895238503081, 04895238503326, 04895238503425, 04895238503074, 04895238503388
Basic UDI-DI
489705918OpticalframeD3
EMDN Code
Q02100203 Metal and plastic spectacle frames without lenses
Device Class
Class I
Market of Registration
Italy
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000037020
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Kelfred Optical Limited

See all devices from Kelfred Optical 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