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Soft Contact Lens
EUDAMEDClass IIa (EU MDR)
Ref CUBE-i 38O142860900
by Medios.Ltd
Identity
- Device Name
- Soft Contact Lens EUDAMED
- Model / Reference
- CUBE-i 38O142860900 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809938610679 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
Soft Contact Lens 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 c8138387-cece-4145-94ab-10b2f23d3230 61 fields · synced Jul 14, 2026