Manufacturer
Hironic
South KoreaLegal entities : Hironic Co., Ltd.
Markets : Poland · Türkiye · United States
Approvals : EU – class IIb · United States (FDA) – 510(k) : 9 · class I, II · latest in 2026 · see on the FDA website
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 |
|---|---|---|---|---|
| Instruments for ultrasonic surgery - hardware accessories | Z12010880 |
|
IIb 93/42 | EUDAMED record Report an error |
| Electrosurgery instruments - consumables | Z12010985 |
|
IIb 93/42 | EUDAMED record Report an error |
| Electrosurgical units (ESU) for general use | Z12010902 |
|
IIb 93/42 | EUDAMED record Report an error |
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