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Hylo Night
EUDAMEDClass IIb (EU MDR)
Ref 55.2525Model Lubricating eye ointmentRef 56.0074Ref 55.2536
Identity
- Trade Name
- HYLO NIGHT EUDAMED
- Device Name
- Lubricating eye ointment with vitamin A EUDAMED
- Model / Reference
- Lubricating eye ointment EUDAMED55.2525 EUDAMED56.0074 EUDAMED55.2536 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04031626001214 EUDAMED04031626001597 EUDAMED04031626001177 EUDAMED
- Basic UDI-DI
- 4031626101888PR EUDAMED
- EMDN Code
- Q02030399 OPHTHALMOLOGY, VISCOELASTIC FLUIDS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Slovakia EUDAMEDAustria EUDAMEDSweden 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 (3)
- EUDAMED 7e6b4d2f-e82d-40dd-9c5e-2f566de0cf97 61 fields · synced Jul 14, 2026
- EUDAMED 521318e9-6b2c-44c3-8fd1-d5472026162b 61 fields · synced May 17, 2026
- EUDAMED c7c90db2-793a-452c-987a-4ae54b6133a7 61 fields · synced May 17, 2026