Identity
- Trade Name
- HYLO FRESH EUDAMED
- Device Name
- Lubricating eye drops with 0.03% sodium hyaluronate EUDAMED
- Model / Reference
- Lubricating eye drops EUDAMED56.0079 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04031626002150 EUDAMED
- Basic UDI-DI
- 4031626103083NM EUDAMED
- EMDN Code
- Q02030301 OPHTHALMOLOGY, HYALURONIC ACID AND DERIVATIVES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Hylo Fresh by URSAPHARM Arzneimittel GmbH — 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 | 4031626103083NM | Class IIb | Active |
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Manufacturer
- Manufacturer
- URSAPHARM Arzneimittel GmbH
- EUDAMED SRN
- DE-MF-000007748
Sources (1)
- EUDAMED 79adb0bc-61fc-4301-8b6d-b3441aa2f47f 61 fields · synced Jul 9, 2026