Identity
- Trade Name
- EIDON FDA UDI
- Generic Name
- Scanning-laser retinal imaging system FDA UDI
- Device Name
- EIDON EUDAMEDEIDON is a scanning ophthalmoscope which uses infrared and visible light to obtain confocal images of the retina, without pharmacological dilation. EIDON is a standalone device. FDA UDI
- Model / Reference
- AMFUNME001 EUDAMEDEIDON FDA UDI
- Description
- EIDON is a scanning ophthalmoscope which uses infrared and visible light to obtain confocal images of the retina, without pharmacological dilation. EIDON is a standalone device. FDA UDI
Identifiers
- Catalog Number
- AMFUNME01 FDA UDI
- Primary DI / UDI-DI
- 08053677040031 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08053677040031 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
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
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 by Centervue S.p.a. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08053677040031 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Centervue S.p.a.
- EUDAMED SRN
- IT-MF-000017082
Sources (2)
- EUDAMED 44195d51-360f-4b53-8618-87abda571c9e 61 fields · synced Aug 1, 2026
- FDA UDI 91f34c58-d301-41fe-a528-2075a82bba13 35 fields · synced May 30, 2026