Identity
- Trade Name
- CUBE-i 38 EUDAMED
- Device Name
- Soft Contact Lens EUDAMED
- Model / Reference
- CUBE-i 38C145870350 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809938617548 EUDAMED
- Basic UDI-DI
- 88061529CUBEI38QH 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
CUBE-i 38 by Medios.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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88061529CUBEI38QH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medios.Ltd
- EUDAMED SRN
- KR-MF-000027930
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED c551fb5f-9ada-4f6f-ba3a-600f459a281c 61 fields · synced Jun 19, 2026