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EyeArt
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 2.1.0510(k) K200667
by Eyenuk, Inc.
Identity
- Trade Name
- EyeArt EUDAMEDFDA UDI
- Generic Name
- Retinal image analysis software FDA UDI
- Device Name
- EyeArt EUDAMED
- Model / Reference
- 2.1.0 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860000470018 EUDAMED00860000470001 FDA UDI
- Basic UDI-DI
- B-00860000470018 EUDAMED
- 510(k) Number
- K200667 FDA UDI
- FDA Product Code
- PIB FDA UDI
- EMDN Code
- Z12120192 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Retinal image analysis software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1100 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
EyeArt by Eyenuk, Inc. — Class IIa — FDA_510K, 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200667 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00860000470018 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Eyenuk, Inc.
- EUDAMED SRN
- US-MF-000004180
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (3)
- EUDAMED 75168b55-12b9-479c-8e09-bf69cfc50908 85 fields · synced Jun 18, 2026
- FDA UDI be5ca8a6-573f-411e-a127-45102cf07283 33 fields · synced May 30, 2026
- FDA 510(k) K200667 1 fields · synced May 18, 2026