Identity
- Trade Name
- FIDIALEYE NORM EUDAMED
- Device Name
- EDENORM EUDAMED
- Model / Reference
- OP06-01 EUDAMED13001254 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055267241477 EUDAMED
- Basic UDI-DI
- 80336618004060100000000TB EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Fidialeye Norm by Fidia Farmaceutici S.p.A. — 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 | 80336618004060100000000TB | Class IIb | Active |
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Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
- EUDAMED SRN
- IT-MF-000026988
Sources (1)
- EUDAMED ec652dc6-74f8-4908-83be-1c192dcf47f6 61 fields · synced Jul 18, 2026