Identity
- Trade Name
- HYLO FRESH EUDAMED
- Device Name
- Lubricating eye drops with 0.03% sodium hyaluronate EUDAMED
- Model / Reference
- Lubricating eye drops EUDAMED55.1053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04031626002280 EUDAMED
- Basic UDI-DI
- 4031626103083NM EUDAMED
- EMDN Code
- Q02030301 OPHTHALMOLOGY, HYALURONIC ACID AND DERIVATIVES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Malta 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 e03e28ce-574c-43c6-b29e-d7072ee827ab 61 fields · synced Jul 12, 2026