Identity
- Trade Name
- NAVITAE EUDAMED
- Device Name
- NAVITAE EUDAMED
- Model / Reference
- D15NVT EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-D15NVT65 EUDAMED
- Basic UDI-DI
- B-D15NVT65 EUDAMED
- EMDN Code
- Q02030206 EYE LUBRICANT SOLUTIONS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Navitae by Novax Pharma SAM — Class IIb — 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-D15NVT65 | Class IIb | 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 3cb88e4f-ea29-405b-93b1-2adbf91aa38b 61 fields · synced Jun 19, 2026