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Tr Frame

by Jiangxi WTO Eyewear Co.，Ltd. 36 variants

Ref EDEN-C3

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697858493CKE Basic UDI-DIDate9 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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 Frames
Model / Reference
EDEN-C3
Primary DI / UDI-DI
06978584933899
Basic UDI-DI
697858493CKE
EMDN Code
Q02100203 Metal and plastic spectacle frames without lenses
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000033171
Authorised representative
Humiss Beratung GmbH DE-AR-000023447

Other devices from Jiangxi WTO Eyewear Co.，Ltd.

See all devices from Jiangxi WTO Eyewear 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