Identity
- Trade Name
- EYE C YOU EUDAMED
- Device Name
- Soft Contact Lens EUDAMED
- Model / Reference
- MCK1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942873001026 EUDAMED
- Basic UDI-DI
- 69422750MCK1RF EUDAMEDB-06942873001026 EUDAMED
- EMDN Code
- Q0210040102 CONTACT LENSES - HYDROGEL, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Eye C You by Gansu Constar Technology Group Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69422750MCK1RF | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69422750MCK1RF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Gansu Constar Technology Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000041579
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (2)
- EUDAMED e17de46f-6f78-4a51-bdfb-d69cea233b0c 61 fields · synced Jul 29, 2026
- EUDAMED 6a758f5c-2255-44c7-aab7-4d87f5c1d093 61 fields · synced Jul 29, 2026