Manufacturer
Empecs
China, South KoreaLegal entities : EMPECS Medical Device Co., Ltd., TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
Markets : Austria · Italy · United States
Approvals : EU – class A · United States (FDA) – 510(k) : 4 · class I, II · latest in 2017 · see on the FDA website
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
- 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 |
|---|---|---|---|---|
| Blood glucose meters | W0201060102 | – 98/79 | EUDAMED record Report an error | |
| Glycosilated hemoglobin devices | W0201060101 | A IVDR | EUDAMED record Report an error |
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