Identity
- Trade Name
- FLORA VISION SPRAY - DRY EYES EUDAMED
- Device Name
- FLORAVISION SPRAY - DRY EYES EUDAMED
- Model / Reference
- S10FD EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-S10FDUG EUDAMED
- Basic UDI-DI
- B-S10FDUG EUDAMED
- EMDN Code
- Q02030206 EYE LUBRICANT SOLUTIONS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece 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
Flora Vision Spray - Dry Eyes 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-S10FDUG | 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 7f08de07-69f7-4eeb-9fe7-39329d7867ef 61 fields · synced Jul 17, 2026