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Oniris

by oniris

Ref ONIPRO2, ONIPRO2SP T2, ONIPRO2ITA, ONIPRO2T1, ONIPRO2TR, ONIPRO2POL, ONIPRO2SP T1, ONIPRO2ES PRO, ONIPRO2ALL510(k) K150566

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150566↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3665389ONIRIS8X Basic UDI-DI Date20 Jan 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK150566 Date21 Mar 2016ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Model / Reference
ONIPRO2, ONIPRO2SP T2, ONIPRO2ITA, ONIPRO2T1, ONIPRO2TR, ONIPRO2POL, ONIPRO2SP T1, ONIPRO2ES PRO, ONIPRO2ALL
Primary DI / UDI-DI
03401051555179, 03665389000033, 03665389000088, 03665389000125, 03665389000217, 03665389000118, 03665389000026, 03665389000095, 03665389000200, 03665389000187
Basic UDI-DI
3665389ONIRIS8X
510(k) Number
FDA Product Code
LRK
EMDN Code
Q03010299 Antisnoring and obstructive sleep apnoea devices - other
Device Class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 872.5570
EU market of registration
France
Italy
Türkiye
Poland
Spain
Germany
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class I
510(k)
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000014182

Other devices from Sas Oniris

See all devices from Sas Oniris →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No