Manufacturer
MacroLux Medical Technology
ChinaLegal entities : MacroLux Medical Technology Co., Ltd.
Markets : Austria · Finland · France · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 7 · class I, II · latest in 2026 · see on the FDA website
EU representative : Wellkang Ltd (Northern Ireland)
- 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 |
|---|---|---|---|---|
| Cystoscopes | Z12020701 | IIa MDR | EUDAMED record Report an error | |
| Hysteroscopes | Z12020704 | IIa MDR | EUDAMED record Report an error | |
| Ureterorenoscopes | Z12020713 | IIa MDR | EUDAMED record Report an error | |
| Video bronchoscopes | Z12020802 | IIa MDR | EUDAMED record Report an error | |
| Video nasopharyngo/laryngoscopes | Z12021006 | IIa MDR | EUDAMED record Report an error | |
| Video processors | Z12020406 | I MDR | EUDAMED record Report an error |
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