Skip to content

Air-Q3 Standard ILA with Manual Cuff Inflation Size 3.0

by SunMed, LLC

Ref 30305Model Air-Q®3 Supraglottic Airway Mask (SGA)

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0889483Air-Q3DF Basic UDI-DI 10889483480106UDI-DIDate24 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10889483480106 UDI-DI Date9 Feb 2025ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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

Trade Name
Air-Q3 Standard ILA with Manual Cuff Inflation Size 3.0 EUDAMED
Air-Q3® GUDID
Generic Name
Laryngeal mask airway, single-use
Model / Ref / Catalog
Air-Q®3 Supraglottic Airway Mask (SGA), 30305
Primary DI / UDI-DI
10889483480106
Basic UDI-DI
0889483Air-Q3DF
FDA Product Code
CAE
EMDN Code
R01020199 Laryngeal masks - other
GMDN Term
Laryngeal mask airway, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5110
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000009164
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from SunMed

See all devices from SunMed →

Properties

  • Sterile
  • Single Use
  • Endocrine Disruptor
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No