Manufacturer
Mediworks
ChinaLegal entities : Shanghai Mediworks Precision Instruments Co., Ltd.
Markets : Austria · France · Germany · Ireland · Italy · Norway · Poland · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 3 · class I, II · latest in 2016 · see on the FDA website
EU representative : CMC Medical Devices & Drugs SL (Spain)
- 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 |
|---|---|---|---|---|
| Slit lamps | Z12120108 | I, IIa MDR | EUDAMED record Report an error | |
| Ophtalmology assessments and diagnosis instruments - other | Z12120199 | I MDR | EUDAMED record Report an error | |
| Various ophtalmology instruments - other | Z12129099 | I, IIa MDR | EUDAMED record Report an error | |
| Operative microscopes | Z12011101 | I MDR | EUDAMED record Report an error | |
| Visual functional assessment equipment | Z1212012001 | I, IIa MDR | EUDAMED record Report an error | |
| Computerised optical biometers | Z12120102 |
|
IIa MDR | EUDAMED record Report an error |
| Ophthalmoscopes | Z12120114 |
|
I MDR | EUDAMED record Report an error |
| Photocheratoscopes | Z12120107 | IIa MDR | EUDAMED record Report an error | |
| Tonometers | Z12120122 | IIa MDR | EUDAMED record Report an error |
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