Identity
- Trade Name
- EYE C YOU EUDAMED
- Device Name
- soft contact lens EUDAMED
- Model / Reference
- MCK1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942873001019 EUDAMED
- Basic UDI-DI
- B-06942873001019 EUDAMED69422750MCK1RF 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 — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06942873001019 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06942873001019 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gansu Constar Technology Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000041579
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (2)
- EUDAMED 77ad34a3-1454-4ed5-ba34-3e904d4b389b 61 fields · synced Jul 20, 2026
- EUDAMED c27d8585-6642-4c41-9781-bf3b2b9a08fe 61 fields · synced Jul 20, 2026