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Optical Frame

by Wenzhou Xinheda Trade co. ltd EUDAMED 2 variants

Active European Union

Ref SONG 001

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697800229FRSGPMU3R Basic UDI-DIDate23 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
Mixed optical frame
Model / Reference
SONG 001
Primary DI / UDI-DI
16978002290037
Basic UDI-DI
697800229FRSGPMU3R
EMDN Code
Q02100203 Metal and plastic spectacle frames without lenses
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000045653
Authorised representative
Humiss Beratung GmbH DE-AR-000023447

Other devices from Wenzhou Xinheda 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