Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 00860000470018
- Basic UDI-DI Code
- B-00860000470018
- Reference
- 2.1.0
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Eyenuk, Inc.
Additional Description
Retinal Image Analysis Software
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12120192 | OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 41302127-00 | INTERTEK SEMKO AB | Expired |
Available In Countries
🇩🇪 Germany
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