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Hylo Dual & Optase Dry Eye Kit
EUDAMEDClass IIb (EU MDR)
Ref HYLO Dual & OPTASE Dry Eye Kit
Identity
- Trade Name
- Hylo Dual & Optase Dry Eye Kit EUDAMED
- Device Name
- HYLO & OPTASE Dry Eye Kit EUDAMED
- Model / Reference
- HYLO Dual & OPTASE Dry Eye Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391531760422 EUDAMED
- Basic UDI-DI
- 5391531optaseDEK01EJ EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- For the management of dry eye, blepharitis and meibomian gland dysfunction. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Hylo Dual & Optase Dry Eye Kit by Scope Ophthalmics Limited — Class IIb — 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 | 5391531optaseDEK01EJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Scope Ophthalmics Limited
- EUDAMED SRN
- IE-PR-000045404
Sources (1)
- EUDAMED a547da99-5c55-425c-a485-f251a43516ab 61 fields · synced Jun 18, 2026