Identity
- Device Name
- NAVIBLEF INTENSIVE CARE EUDAMED
- Model / Reference
- F50NI EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-F50NIRX EUDAMED
- Basic UDI-DI
- B-F50NIRX EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Naviblef Intensive Care by Novax Pharma SAM — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-F50NIRX | Class I | Active |
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Manufacturer
- Manufacturer
- Novax Pharma SAM
- EUDAMED SRN
- MC-MF-000011256
- Authorised Representative
- International Associates Auditing & Certification Limited IE-AR-000002248
Sources (1)
- EUDAMED c82c28d6-4340-4d4e-84fb-fb8516fc420a 61 fields · synced Jul 26, 2026