Manufacturer
Shenzhen Dongdixin Technology
ChinaLegal entities : Shenzhen Dongdixin Technology Co., Ltd.
Markets : France · Germany · Spain · Sweden · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 27 · class I, II · latest in 2026 · 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 |
|---|---|---|---|---|
| Neuromuscular stimulation equipment - other | Z12062899 |
3 others
|
IIa MDR, 93/42 | EUDAMED record Report an error |
| Ultrasound therapy equipment | Z120610 | IIa 93/42 | EUDAMED record Report an error | |
| Magnetotherapy equipment | Z120606 | I, IIa MDR, 93/42 | EUDAMED record Report an error | |
| Tens system electrodes | N010201 | I MDR | EUDAMED record Report an error | |
| Contact digital thermometers (including probes) | V0301010201 | IIa MDR | EUDAMED record Report an error | |
| Electrotherapy equipment (included tens) | Z120601 | IIa MDR | EUDAMED record Report an error | |
| Non-contact digital thermometers | V0301010202 | IIa MDR | EUDAMED record Report an error |
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