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Contact lens

by ST. Shine Optical Co., Ltd. Taiwan EUDAMED

Ref ZD53, ZD55, ZD23, ZD42ZZ, ZD44ZZ, ZD43ZZ, ZD41ZZ, ZD21, ZD50ZZ, ZD57ZZ, ZD47ZZ, ZD73Z0, ZD75ZZ, ZD27, ZD46ZZ, ZD45ZZ, ZD58ZZ, ZD42Z0Model 57% Methafilcon, 55% Methafilcon A, 42% Hefilcon A, 45% SB, 60% Omafilcon A, 38% Senofilcon A

EMDN Q021004010101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number47198751557ML9 Basic UDI-DIDate12 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
57% Methafilcon, ZD53, ZD55, 55% Methafilcon A, ZD23, 42% Hefilcon A, ZD42ZZ, 45% SB, ZD44ZZ, ZD43ZZ, ZD41ZZ, ZD21, ZD50ZZ, 60% Omafilcon A, ZD57ZZ, ZD47ZZ, ZD73Z0, ZD75ZZ, ZD27, ZD46ZZ, ZD45ZZ, 38% Senofilcon A, ZD58ZZ, ZD42Z0
Primary DI / UDI-DI
04719887138503, 04719887138527, 04719887087627, 471987515ZD42ZZNJ, 471987515ZD44ZZNU, 471987515ZD43ZZNP, 471987515ZD41ZZND, 04719887087603, 471987515ZD50ZZNF, 471987515ZD57ZZPJ, 471987515ZD47ZZPB, 471987515ZD73Z0LS, 471987515ZD75ZZPN, 04719887087665, 471987515ZD46ZZP6, 471987515ZD45ZZNZ, 471987515ZD58ZZPP, 471987515ZD42Z0KY
Basic UDI-DI
47198751557ML9, 47198751555ML3, 47198751542HKB, 47198751545SLA, 47198751560OKV, 47198751538SLE
EMDN Code
Q021004010101, Q0210040102, X01010101
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

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (18)

  • EUDAMED b004178a-7313-4eff-8faf-bb9113420d81 61 fields · synced 22 Oct 2026
  • EUDAMED 04719887138527|47198751557ML9 61 fields · synced 18 May 2026
  • EUDAMED 04719887087627|47198751555ML3 61 fields · synced 18 May 2026
  • EUDAMED 471987515ZD42ZZNJ|47198751542HKB 61 fields · synced 12 Jul 2026
  • EUDAMED 471987515ZD44ZZNU|47198751545SLA 61 fields · synced 12 Jul 2026
  • EUDAMED 471987515ZD43ZZNP|47198751545SLA 61 fields · synced 13 Jul 2026
  • EUDAMED 471987515ZD41ZZND|47198751542HKB 61 fields · synced 15 Jul 2026
  • EUDAMED 04719887087603|47198751555ML3 61 fields · synced 16 Jul 2026
  • EUDAMED 471987515ZD50ZZNF|47198751545SLA 61 fields · synced 16 Jul 2026
  • EUDAMED 471987515ZD57ZZPJ|47198751560OKV 61 fields · synced 21 Jul 2026
  • EUDAMED 471987515ZD47ZZPB|47198751545SLA 61 fields · synced 22 Jul 2026
  • EUDAMED 471987515ZD73Z0LS|47198751542HKB 61 fields · synced 22 Jul 2026
  • EUDAMED 471987515ZD75ZZPN|47198751542HKB 61 fields · synced 23 Jul 2026
  • EUDAMED 04719887087665|47198751555ML3 61 fields · synced 23 Jul 2026
  • EUDAMED 471987515ZD46ZZP6|47198751545SLA 61 fields · synced 27 Jul 2026
  • EUDAMED 471987515ZD45ZZNZ|47198751545SLA 61 fields · synced 30 Jul 2026
  • EUDAMED 471987515ZD58ZZPP|47198751538SLE 61 fields · synced 4 Aug 2026
  • EUDAMED 471987515ZD42Z0KY|47198751542HKB 61 fields · synced 17 Sep 2026