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X-Smart® Pro+ WaveOne® Gold kit

EUDAMED

Class IIa (EU MDR)

Ref B00XSPPW1GKITModel B00XSP0W1GKIT

by Maillefer Instruments Holding Sàrl

Identity

Trade Name: X-Smart® Pro+ WaveOne® Gold kit EUDAMED
Device Name: X-Smart® Pro WaveOne® Gold kit EUDAMED
Model / Reference: B00XSP0W1GKIT EUDAMED
B00XSPPW1GKIT EUDAMED

Identifiers

Primary DI / UDI-DI: +J003B00XSPPW1GKIT1 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

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Manufacturer

Manufacturer: Maillefer Instruments Holding Sàrl
EUDAMED SRN: CH-PR-000022681

Sources (1)

EUDAMED f9d9b10c-a378-4906-a004-1811c2e69e5a 61 fields · synced Jun 17, 2026