Identity
- Trade Name
- EIDON FA EUDAMEDEIDON FDA UDI
- Generic Name
- Scanning-laser retinal imaging system FDA UDI
- Device Name
- EIDON Family EUDAMEDEIDON FA EUDAMEDThe CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and auto-fluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent. FDA UDI
- Model / Reference
- AIFLAME001 EUDAMEDEIDON FA FDA UDI
- Description
- The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and auto-fluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent. FDA UDI
Identifiers
- Catalog Number
- APFLAOP100 FDA UDI
- Primary DI / UDI-DI
- 08053677040093 EUDAMEDFDA UDI
- Basic UDI-DI
- 805367704Eidon-FamilyUV EUDAMEDB-08053677040093 EUDAMED
- Direct Marketing DI
- 08053677040093 EUDAMED
- 510(k) Number
- K180526 FDA UDI
- FDA Product Code
- MYC FDA UDIHKI FDA UDI
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Scanning-laser retinal imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1570 FDA UDI886.1120 FDA UDI
- Market of Registration
- Italy EUDAMEDTürkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Eidon Fa by Centervue S.p.a. — Class IIa — MDD, FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 805367704Eidon-FamilyUV | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K180526 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805367704Eidon-FamilyUV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Centervue S.p.a.
- EUDAMED SRN
- IT-MF-000017082
Sources (4)
- EUDAMED fa901a9d-3019-45ed-8211-61f0b8cc67b5 61 fields · synced Sep 18, 2026
- FDA UDI 8909ce1b-bd1a-4133-ad65-a4589cfd8922 35 fields · synced May 30, 2026
- EUDAMED b9b7bb5c-587b-448e-b7c1-85f3bbf8b832 61 fields · synced Jul 12, 2026
- FDA 510(k) K180526 1 fields · synced May 18, 2026