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Laryseal 038-94-730U

by Flexicare Medical Limited

Ref 038-94-730U

Laryseal 038-94-730U is a device classified as Class IIa in the EU and Class I in the US made by Flexicare Medical Limited, registered in EUDAMED on 18 Aug 2026 (Basic UDI-DI B-05055788713555) and listed in FDA GUDID since 8 Mar 2024 (UDI-DI 05055788713555), active as of 22 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055788713555 Basic UDI-DI 05055788713555UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055788713555 UDI-DI Date8 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05055788713555 registered 18 Aug 2026 Active
  • FDA GUDID UDI-DI 05055788713555 listed 8 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05055788713555
  2. Registered EUDAMED B-05055788713555

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Flexicare EUDAMED
Laryseal GUDID
Generic name
Laryngeal mask airway, single-use
Device name
Laryngeal Mask Airways
Model / reference
038-94-730U
Primary DI / UDI-DI
05055788713555
Basic UDI-DI
B-05055788713555
FDA product code
CAE
EMDN code
R01020101 Laryngeal masks, single-lumen
GMDN term
Laryngeal mask airway, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5110
EU registration type
Legacy device (under a directive)
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Supplied sterileEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 05055788713555: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Laryngeal mask airway, single-use

Similar devices in this category

Other devices filed under LARYNGEAL MASKS, SINGLE-LUMEN.

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)