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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

ONIRIS PLUS — Class I MDR by oniris

MD Atlas
oniris

EUDAMED last updated this device on May 11, 2026

ONIRIS PLUS

3665389ONIRIS8X

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: oniris
UDI-DI code: 03665389000316
Reference / catalog number: ONIPLUSBEL

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Manufacturer information

Organization name: oniris
SRN: FR-MF-000014182
Manufacturer status: Active

Related devices

ONIPRO2ES3665389ONIRIS8XOn the market ONIRIS3665389ONIRIS8XOn the market ONIRIS3665389ONIRIS8XOn the market ONIPRO2TR3665389ONIRIS8XOn the market ONIPRO2ALL3665389ONIRIS8XOn the market

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.

Critical warnings

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

CW999
OTHER: L'orthèse Oniris n'est pas adaptée aux personnes ayant moins de 8 dents naturelles par mâchoire (4 de chaque côté), à l'exception des personnes ayant un appareil amovible complet à la mâchoire supérieure ou un appareil complet fixé sur 2 implants type Locator à la mâchoire inférieure, présentant une mobilité dentaire, une maladie ou complication de la gencive ou du parodonte, souffrant de réflexe nauséeux incœrcible, sujettes à l'épilepsie non contrôlée ou mineure, traitement orthodontique en cours. Ceci s'applique également si vous avez encore un fil dentaire après un traitement orthodontique ou si vous avez des facettes. En cas de doute consulter impérativement un spécialiste dentaire ou ORL.

Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement	Jan 1, 2026	Still on market

Device identification

Trade name: ONIRIS PLUS
UDI-DI code: 03665389000316
Basic UDI-DI: 3665389ONIRIS8X
Reference / catalog number: ONIPLUSBEL
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Oniris est une orthèse d'avancée mandibulaire qui repositionne la mâchoire du bas légèrement en avant et libère les voies respiratoires. Les ronflements et les apnées sont ainsi réduits ou supprimés.
Additional information URL: https://www.oniris-ronflement.fr/comment-ca-marche/mode-emploi/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q03010299ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER

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

UDI-PI traceability

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Software identification