Skip to content

eXciteOSA

by Signifier Medical Technologies Limited 2 variants

Ref eXciteOSA mouthpiece

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05060627480017 UDI-DI Date14 Aug 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number50606274800086 Basic UDI-DI 05060627480017UDI-DIDate11 Oct 2023RegisteredStatusActive

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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Sleep-disordered breathing tongue electrical stimulator
Model / Reference
eXciteOSA mouthpiece EUDAMED
801600001 GUDID
Primary DI / UDI-DI
05060627480017
Basic UDI-DI
50606274800086
Direct Marketing DI
05060627480017
FDA Product Code
QNO
EMDN Code
Q03010299 Antisnoring and obstructive sleep apnoea devices - other
GMDN Term
Sleep-disordered breathing tongue electrical stimulator
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.5575
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
eXciteOSA mouthpiece
GUDID
801600001
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
GB-MF-000035054
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Signifier Medical Technologies, Ltd.

Properties

  • Serial Number
  • Manufacturing Date

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No