Eu Mdd
Eu Md Class 2a
No Longer On The Market
🇺🇸 United States
MaculoScope
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00855730007412
- Basic UDI-DI Code
- B-00855730007412
- Reference
- D130
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- No Longer On The Market
- Manufacturer
- Diagnosys LLC
Additional Description
Electrophysiology system that conducts focal ERG tests.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1212012001 | VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 41313861 | INTERTEK SEMKO AB |
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