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Lma Atomization IPN915310

by Teleflex Incorporated United States EUDAMEDGUDID

Ref MAD700

Product code CCTEMDN R9099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08019020000000000000096KX Basic UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14026704709882 UDI-DIDate31 Aug 2023ListedStatusIn distribution

Coverage

2 jurisdictions

United 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 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 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 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 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

3 recalls · FDA

    • Terminated Z-3212-2017 FDA Class II initiated 5 Jul 2017

    Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.

  • 2 recalls, same reason

    • Terminated Z-0384-2017 FDA Class II initiated 27 Oct 2016
    • Terminated Z-0383-2017 FDA Class II initiated 27 Oct 2016 via K153470, on the same 510(k)

    Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
MADgic Atomizer without Syringe EUDAMED
Lma Atomization GUDID
Generic Name
Laryngotracheal anaesthesia applicator
Device Name
MADgic
Model / Ref / Catalog
MAD700, IPN915310
Primary DI / UDI-DI
14026704709882
Basic UDI-DI
08019020000000000000096KX
510(k) Number
FDA Product Code
CCT
EMDN Code
R9099 Respiratory and anaesthesia devices - other
GMDN Term
Laryngotracheal anaesthesia applicator
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
868.5170
Market of Registration
Ireland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MAD700
GUDID
IPN915310
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Laryngotracheal anaesthesia applicator

Cleared under the same submission (K153470)

Show all (12)

Other devices from Teleflex Incorporated

See all devices from Teleflex Incorporated →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Administering Medicine
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (17)
  • Sterile: 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (2)

  • FDA UDI bdfb7be2-e72b-417a-b542-f3af6296872b 36 fields · synced 24 Oct 2026
  • EUDAMED 14026704709882|08019020000000000000096KX 61 fields · synced 24 Oct 2026