Manufacturer
Shenyang Shenda Endoscope
ChinaLegal entities : Shenyang Shenda Endoscope Co., Ltd.
Markets : Austria · Belgium · Bulgaria · Croatia · Netherlands · Northern Ireland · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 1 · class II · latest in 2017 · see on the FDA website
EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images | Z12020401 |
1 other |
I MDR | EUDAMED record Report an error |
| Laparoscopes | Z12029009 | IIa MDR | EUDAMED record Report an error | |
| Light sources for endoscopy and minimally invasive surgery | Z12020402 | I MDR | EUDAMED record Report an error | |
| Hysteroscopes | Z12020704 |
|
IIa MDR | EUDAMED record Report an error |
| Arthroscopes | Z12021101 |
|
IIa MDR | EUDAMED record Report an error |
| Cystoscopes | Z12020701 |
|
IIa MDR | EUDAMED record Report an error |
| Resectoscopes | Z12020707 |
|
IIa MDR | EUDAMED record Report an error |
| Rhinoscopes | Z12021008 |
|
I MDR | EUDAMED record Report an error |
| Video nasopharyngo/laryngoscopes | Z12021006 |
|
I MDR | EUDAMED record Report an error |
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