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WaveOne® Gold
EUDAMEDClass IIa (EU MDR)
Ref BDDW1G1316OSHModel WaveOne Gold (SU, NiTi, Ro, MSA)
Identity
- Trade Name
- WaveOne® Gold EUDAMED
- Device Name
- WaveOne® Gold EUDAMED
- Model / Reference
- WaveOne Gold (SU, NiTi, Ro, MSA) EUDAMEDBDDW1G1316OSH EUDAMED
Identifiers
- Primary DI / UDI-DI
- +J003BDDW1G1316OSH1 EUDAMED
- Basic UDI-DI
- ++J00310039E8 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
WaveOne® Gold 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 | ++J00310039E8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Maillefer Instruments Holding Sàrl
- EUDAMED SRN
- CH-MF-000016301
- Authorised Representative
- Dentsply DeTrey GmbH DE-AR-000005904
Sources (1)
- EUDAMED 4d744c0d-fedb-43d2-baca-9ee5971bbe96 61 fields · synced Jun 19, 2026