Manufacturer
Gulden Ophthalmics
United States
Markets : Belgium · United States
Approvals : EU – class I · United States (FDA) – 510(k) : 1 · class I, II · latest in 1997 · see on the FDA website
EU representative : QbD RepS BV (Belgium)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Ophtalmology assessments and diagnosis instruments - other | Z12120199 | I MDR | EUDAMED record Report an error | |
| Therapeutic and surgical ophtholmological treatments instruments - other | Z12120299 |
|
I MDR | EUDAMED record Report an error |
| Cross-eye convergence trainers | Z12120201 | I MDR | EUDAMED record Report an error | |
| General auditory and/or visual stimulators | Z129013 |
|
I MDR | EUDAMED record Report an error |
| Instruments for the assessment of visual functionality - other | Z1212012099 | I MDR | EUDAMED record Report an error | |
| Visual functional assessment equipment | Z1212012001 |
|
I MDR | EUDAMED record Report an error |
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