Identity
- Trade Name
- HYLO NIGHT EUDAMED
- Device Name
- Lubricating eye ointment with vitamin A EUDAMED
- Model / Reference
- Lubricating eye ointment EUDAMED56.0075 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04031626001689 EUDAMED
- Basic UDI-DI
- 4031626101888PR EUDAMED
- EMDN Code
- Q02030399 OPHTHALMOLOGY, VISCOELASTIC FLUIDS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hylo Night 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 | 4031626101888PR | Class IIb | Active |
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Manufacturer
- Manufacturer
- URSAPHARM Arzneimittel GmbH
- EUDAMED SRN
- DE-MF-000007748
Sources (1)
- EUDAMED 90b86b50-a997-403f-be5d-7f7d5a1da760 61 fields · synced Jun 19, 2026