Identity
- Trade Name
- Oculoheel Ojo seco EUDAMED
- Device Name
- Eyelid Spray EUDAMED
- Model / Reference
- 19474 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052990631100 EUDAMED
- Basic UDI-DI
- 805299063OFTASPRAY001KC EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
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
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oculoheel Ojo seco by Nirial Pharma srl — 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 | 805299063OFTASPRAY001KC | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nirial Pharma srl
- EUDAMED SRN
- IT-MF-000018760
Sources (1)
- EUDAMED 6dafceda-5947-49ba-ac02-a8c52d384129 61 fields · synced Oct 6, 2026