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Contact lens

by ST. Shine Optical Co., Ltd. 24 variants

Ref ZD39ZZModel 42% Hefilcon A

Active European Union

CE MDR

Valid until

19 Sep 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number47198751542HKB Basic UDI-DI 471987515ZD39ZZPEUDI-DIDate21 May 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • TW25/00000878 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    26 Jan 2026
    Expires
    19 Sep 2030

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Contact lens
Model / Reference
42% Hefilcon A, ZD39ZZ
Primary DI / UDI-DI
471987515ZD39ZZPE
Basic UDI-DI
47198751542HKB
EMDN Code
Q021004010101 Contact lenses - hydrogel, daily single-use
Device Class
Class IIa
Special Device Type
Standard soft contact lenses

Manufacturer details

EUDAMED SRN
TW-MF-000008432
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from St. Shine Optical Co., Ltd.

See all devices from St. Shine Optical Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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