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i-view

EUDAMED

Class IIa (EU MDR)

Ref manyModel i-view

by ILEN Co., Ltd.

Identity

Model / Reference
i-view EUDAMED
many EUDAMED

Identifiers

Primary DI / UDI-DI
88001855i-view14086TX4 EUDAMED
88001855i-view14086SX2 EUDAMED
88001855i-view19090SYC EUDAMED
88001855i-view14084SWU EUDAMED
88001855i-view15086TXF EUDAMED
88001855i-view14286TXJ EUDAMED
88001855i-view14284TXC EUDAMED
Basic UDI-DI
88001855i-view86 EUDAMED
EMDN Code
Q0210040102 CONTACT LENSES - HYDROGEL, REUSABLE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Special Device Type
Standard soft contact lenses EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

i-view by ILEN Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
ILEN Co., Ltd.
EUDAMED SRN
KR-MF-000040382
Authorised Representative
S.B. Pharma GmbH DE-AR-000005392

Sources (7)

  • EUDAMED 195a1afe-d93b-4afc-9141-46b6893c1d3a 61 fields · synced Jul 19, 2026
  • EUDAMED acf2679d-3418-4569-96ec-ebba8b75e758 61 fields · synced May 16, 2026
  • EUDAMED ed50148e-9b94-4981-aa13-633e87e3d5f8 61 fields · synced May 16, 2026
  • EUDAMED 0541841c-61d7-4229-b335-2d0b7811a8ff 61 fields · synced May 17, 2026
  • EUDAMED 24e3b2d4-2541-44b1-a5c9-a84ebccb903b 61 fields · synced May 18, 2026
  • EUDAMED 883718b6-5bdf-4889-bc83-e18a6372190b 61 fields · synced May 19, 2026
  • EUDAMED dc15106f-baf6-41c4-a33f-98946b37e8e4 61 fields · synced May 19, 2026