Manufacturer
Aligntech
China, IsraelLegal entities : Align Technology (Sichuan) Medical Equipment Co.,Ltd., Align Technology Ltd.
Markets : Netherlands · Sweden · Türkiye · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 16 · class I, II · latest in 2026 · see on the FDA website
Public contracts won : Sweden 2
EU representative : Align Technology 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 |
|---|---|---|---|---|
| Laser imaging scanner | Z110601 | I, IIa MDR | EUDAMED record Report an error | |
| Various dental stomatology instruments - consumables | Z12119085 | I, IIa MDR | EUDAMED record Report an error |
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