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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

ONIPLUSES — Class I MDR by oniris

MD Atlas
oniris

EUDAMED last updated this device on May 9, 2026

ONIPLUSES

3665389ONIRIS8X

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: oniris
UDI-DI code: 03665389000309
Reference / catalog number: ONIPLUSES

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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
El dispositivo Oniris no es adecuado para las personas afectadas con ronquido de origen nasal; para las personas que tienen dientes que se mueven, afectadas con una enfermedad o complicaciones infecciosas de las encías o del periodonto; para las personas afectadas con reflejo nauseoso incoercible; para las personas afectadas de epilepsia; para las personas menores de edad; durante tratamiento ortodóncico para las personas que tengan menos de 8 dientes naturales por maxilar (4 en cada lado), excepto para aquellas que tengan una dentadura completa extraíble en el maxilar superior o una dentadura completa unida a 2 implantes tipo Locator en el maxilar inferior. Esto también se aplica si todavía tiene el retenedor de alambre después de un tratamiento de ortodoncia o si tiene carillas. En caso de duda, consulte obligatoriamente con su médico general o de familia.

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 03665389000309
Basic UDI-DI: 3665389ONIRIS8X
Reference / catalog number: ONIPLUSES
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 es un dispositivo de avance mandibular que coloca la mandíbula inferior ligeramente adelantada y libera las vías respiratorias. De este modo, se reducen e incluso desaparecen los ronquidos y las apneas.
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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