Identity
- Trade Name
- WaveOne® Gold and SDR® flow+ kit EUDAMED
- Device Name
- WaveOne® Gold and SDR flow+ kit EUDAMED
- Model / Reference
- B00WSDRR2CKIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- +J003B00WSDRR2CKIT1 EUDAMED
- Basic UDI-DI
- ++J00310153E7 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
WaveOne® Gold and SDR® flow+ kit by Maillefer Instruments Holding Sàrl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++J00310153E7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Maillefer Instruments Holding Sàrl
- EUDAMED SRN
- CH-PR-000022681
Sources (1)
- EUDAMED 63afa971-4290-4ae5-938f-d83b8b530943 61 fields · synced Jul 9, 2026