Manufacturer
Bistos
South KoreaLegal entities : Bistos Co., Ltd.
First countries of placing on the market declared in EUDAMED : Austria, France, Germany, Italy, Poland, Spain
EU representative : Obelis s.a. (Belgium)
- 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 |
|---|---|---|---|---|
| Foetal heartbeat detectors | Z12080103 |
|
IIa 93/42 | EUDAMED record Report an error |
| Transportable/portable multi-parameter patient monitors | Z1203020202 | IIb 93/42 | EUDAMED record Report an error | |
| Breast pumps | Z12080303 |
|
IIa 93/42 | EUDAMED record Report an error |
| Foetal monitors | Z12080101 | IIa, IIb MDR, 93/42 | EUDAMED record Report an error | |
| Fixed neonatal incubators | Z1208040301 |
|
IIb 93/42 | EUDAMED record Report an error |
| Light sources | Z129004 |
|
I MDR | EUDAMED record Report an error |
| Neonatal radiant warmers | Z12080407 |
|
IIb 93/42 | EUDAMED record Report an error |
| Paediatric phototherapy equipment | Z12080401 |
|
IIa 93/42 | EUDAMED record Report an error |
| Pulse oximeters | Z1203020408 |
|
IIb 93/42 | EUDAMED record Report an error |
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