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WENZHOU TIDE-OPTICAL CO., Ltd

by Wenzhou Tide-Optical Co., Ltd 35 variants

Ref SO 52078Model SO 52078 512/SO 52078 533/SO 52078 543/SO 52078 544/SO 52078 612/SO 52078 633/SO 52078 643/SO 52078 644

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 Number697421356SO52078HV Basic UDI-DI 06974213567084UDI-DIDate3 Sep 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  • Withdrawn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

Model / Reference
SO 52078 512/SO 52078 533/SO 52078 543/SO 52078 544/SO 52078 612/SO 52078 633/SO 52078 643/SO 52078 644, SO 52078
Primary DI / UDI-DI
06974213567084
Basic UDI-DI
697421356SO52078HV
EMDN Code
Q02100202 Plastic spectacle frames without lenses
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000009512
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from Wenzhou Tide-Optical Co., Ltd

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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