Identity
- Trade Name
- X-Smart® Pro WaveOne® Gold kit EUDAMED
- Device Name
- X-Smart® Pro WaveOne® Gold kit EUDAMED
- Model / Reference
- B00XSP0W1GKIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- +J003B00XSP0W1GKIT1 EUDAMED
- Basic UDI-DI
- ++J00310135E5 EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- This procedure pack is intended to be used for treatment of endodontic disease (root canal treatment). EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
X-Smart® Pro WaveOne® Gold kit by Maillefer Instruments Holding Sàrl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++J00310135E5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Maillefer Instruments Holding Sàrl
- EUDAMED SRN
- CH-PR-000022681
Sources (1)
- EUDAMED 94995875-736c-4414-8fe6-02e2be1815c8 61 fields · synced Jun 18, 2026