Manufacturer
Spectranetics
United StatesLegal entities : Spectranetics Corporation
Markets : France · Netherlands · Sweden · United States
Approvals : EU – class IIb · United States (FDA) – 510(k) : 44 · PMA : 5 · class II, III · latest in 2026 · see on the FDA website
Public contracts won : France 9 · Sweden 1
EU representative : Spectranetics International 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 |
|---|---|---|---|---|
| Excimer surgical laser | Z12011001 |
|
IIb 93/42 | EUDAMED record Report an error |
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