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Eidon Af
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref AIFLUME001510(k) K142047
Identity
- Trade Name
- EIDON AF EUDAMEDEIDON FDA UDI
- Generic Name
- Scanning-laser retinal imaging system FDA UDI
- Device Name
- EIDON AF EUDAMEDEIDON Family EUDAMEDEIDON AF (Eidon from Greek eidou, “to see” and AF, AutoFluorescence) is a scanning ophthalmoscope which uses infrared and visible light to obtain confocal infrared reflectance images, confocal visible reflectance images of the retina and fluorescence images of the retina, without pharmacological dilation. EIDON is a standalone device. FDA UDI
- Model / Reference
- AIFLUME001 EUDAMEDEIDON AF FDA UDI
- Description
- EIDON AF (Eidon from Greek eidou, “to see” and AF, AutoFluorescence) is a scanning ophthalmoscope which uses infrared and visible light to obtain confocal infrared reflectance images, confocal visible reflectance images of the retina and fluorescence images of the retina, without pharmacological dilation. EIDON is a standalone device. FDA UDI
Identifiers
- Catalog Number
- AIFLUME001 FDA UDI
- Primary DI / UDI-DI
- 08053677040079 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08053677040079 EUDAMED805367704Eidon-FamilyUV EUDAMED
- Direct Marketing DI
- 08053677040079 EUDAMED
- 510(k) Number
- K142047 FDA UDI
- FDA Product Code
- MYC 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 UDI
- Market of Registration
- Italy 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 Af by Centervue S.p.a. — Class IIa — FDA_510K, MDR, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142047 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-08053677040079 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08053677040079 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Centervue S.p.a.
- EUDAMED SRN
- IT-MF-000017082
Sources (4)
- EUDAMED 4120e4ad-a4a8-460b-8543-1fe3a4bca897 85 fields · synced Jun 18, 2026
- EUDAMED 3fa1d2b2-fd79-4c63-8b45-b842fe5e7c1e 61 fields · synced May 17, 2026
- FDA UDI b241e6b3-98a3-49cc-b00c-31360e8bca43 35 fields · synced May 25, 2026
- FDA 510(k) K142047 1 fields · synced May 18, 2026