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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

WaveOne® Gold — Class IIa MDR by Maillefer Instruments…

MD Atlas
Maillefer Instruments Holding Sàrl

EUDAMED last updated this device on May 28, 2026

WaveOne® Gold

++J00310039E8

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Maillefer Instruments Holding Sàrl
UDI-DI code: +J003BDDW1G1316OSH1
Reference / catalog number: BDDW1G1316OSH

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View device family (Basic UDI)

Manufacturer information

Organization name: Maillefer Instruments Holding Sàrl
SRN: CH-MF-000016301
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
Consult instructions for use

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Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement		Still on market

Device identification

Trade name: WaveOne® Gold
UDI-DI code: +J003BDDW1G1316OSH1
Basic UDI-DI: ++J00310039E8
Reference / catalog number: BDDW1G1316OSH
Issuing entity: HIBCC

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Endodontic Instrument
Additional information URL: https://dentsplysirona.com/ifu
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

+J003BDDW1G1316OSH1

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q010507ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.