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Apnea Guard

EUDAMEDFDA UDI

Class I (EU MDR)

Ref AG25-1012

by Advanced Brain Monitoring, Inc.

Identity

Trade Name
Apnea Guard EUDAMEDFDA UDI
Generic Name
Silicone dental impression material FDA UDI
Device Name
Apnea Guard EUDAMED
Apnea Guard Starter Kit 2L2M1H (V2 OEM) FDA UDI
Model / Reference
AG25-1012 EUDAMEDFDA UDI
Description
Apnea Guard Starter Kit 2L2M1H (V2 OEM) FDA UDI

Identifiers

Primary DI / UDI-DI
00850063034029 EUDAMEDFDA UDI
Basic UDI-DI
0851113007AG25SPPJ9 EUDAMED
FDA Product Code
ELW FDA UDI
LRK FDA UDI
EMDN Code
Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER EUDAMED
GMDN Term
Silicone dental impression material FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
872.3660 FDA UDI
872.5570 FDA UDI
Medical Purpose
The Apnea Guard is a mandibular repositioning device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older. The Apnea Guard is intended to be fitted with assistance from a healthcare professional, and used during sleep for less than 30-nights. EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Apnea Guard by Advanced Brain Monitoring, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Brain Monitoring, Inc.
EUDAMED SRN
US-PR-000044717

Sources (2)

  • EUDAMED 4454712f-b60a-4cb2-aab9-d9327e21d617 61 fields · synced Oct 9, 2026
  • FDA UDI a3ade35a-a468-4189-bf3b-6f2fcca94ba3 34 fields · synced May 30, 2026