Identity
- Trade Name
- Hyper-CL EUDAMED
- Device Name
- Hyper-CL EUDAMED
- Model / Reference
- KIT-003-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17290016352228 EUDAMED
- Basic UDI-DI
- B-17290016352228 EUDAMED
- EMDN Code
- Q021004010102 CONTACT LENSES - HYDROGEL, EXTENDED SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hyper-CL by EyeYon Medical Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-17290016352228 | Class IIa | Active |
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Manufacturer
- Manufacturer
- EyeYon Medical Ltd.
- EUDAMED SRN
- IL-MF-000016053
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (1)
- EUDAMED 204c51a4-7eb0-43bd-af98-f7d779626724 61 fields · synced Jul 25, 2026