Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 08053610750003
- Basic UDI-DI Code
- 805361075OPHJW
- Reference
- OPH_IT
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- MR DOC S.R.L.
Additional Description
Software as a Medical Device for the automatic processing of retinal OCT images, providing specialist medical personnel with useful information for the diagnosis of Diabetic Macular Edema, for monitoring the progression of the disease over time and the effectiveness of any treatments, and for estimating the patient's retinal inflammation status.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12120192 | OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE |
Available In Countries
🇮🇹 Italy
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