Manufacturer
GaleMed
China, TaiwanLegal entities : GaleMed (Xiamen) Co., Ltd., GaleMed Corporation
Markets : Austria · Cyprus · Germany · Netherlands · Slovenia · United States
Approvals : EU – class I · United States (FDA) – 510(k) : 7 · class I, II · latest in 2014 · see on the FDA website
EU representative : Emergo Europe B.V. (Netherlands)
- 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 |
|---|---|---|---|---|
| Devices with measuring functions - accessories | V0380 | I MDR | EUDAMED record Report an error | |
| Peak flow spirometers | Z12150102 | I MDR | EUDAMED record Report an error | |
| Spirometry instruments - hardware accessories | Z12150180 |
|
I MDR | EUDAMED record Report an error |
| Spirometry instruments - other | Z12150199 |
|
I MDR | EUDAMED record Report an error |
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