Skip to content

Apnea Guard

by Advanced Brain Monitoring, Inc. United States EUDAMED510(k)GUDID

Ref AG25-1003.10(SPA) Product code LRKEMDN Q03010299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0851113007AG25JT Basic UDI-DIDate22 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number30850015266028 UDI-DIDate27 Sep 2021ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK111110 Date22 Jul 2011IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Generic Name
Mandible-repositioning sleep-disordered breathing orthosis
Model / Reference
AG25-1003.10(SPA)
Primary DI / UDI-DI
30850015266028
Basic UDI-DI
0851113007AG25JT
510(k) Number
FDA Product Code
LRK
EMDN Code
Q03010299 Antisnoring and obstructive sleep apnoea devices - other
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.5570
Market of Registration
Spain
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000011252
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

Other devices from Advanced Brain Monitoring, Inc.

See all devices from Advanced Brain Monitoring, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date
Other properties (21)
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No

Sources (3)

  • EUDAMED 0308741f-e1fd-4c63-9e9e-505277f1b265 61 fields · synced 24 Oct 2026
  • FDA UDI 1334dd51-faf2-47a0-b4a8-be0591df79a5 35 fields · synced 30 May 2026
  • FDA 510(k) K111110 1 fields · synced 19 May 2026