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Teleflex IPN922102

by Teleflex Incorporated

Ref VAX300

Teleflex IPN922102 (VAX300) is an atomizer (EU MDR Class I; FDA Class I; FDA product code CCQ, Nebulizer, Medicinal, Non-Ventilatory (Atomizer)) made by Teleflex Incorporated, registered in EUDAMED on 11 Aug 2026 (Basic UDI-DI 08019020000000000000161KH) and listed in FDA GUDID since 31 Mar 2023 (UDI-DI 14026704738387), active as of 24 Oct 2026.

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

CE MDR

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08019020000000000000161KH Basic UDI-DI 14026704738387UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14026704738387 UDI-DI Date31 Mar 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08019020000000000000161KH registered 11 Aug 2026 Active
  • FDA GUDID UDI-DI 14026704738387 listed 31 Mar 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 14026704738387
  2. Registered EUDAMED 08019020000000000000161KH

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  • Withdrawn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
Intranasal Atomization Device EUDAMED
Teleflex GUDID
Generic name
Atomizer, non-ventilatory
Device name
VaxINator
Model / Ref / Catalog
VAX300, IPN922102
Primary DI / UDI-DI
14026704738387
Basic UDI-DI
08019020000000000000161KH
FDA product code
CCQ
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Atomizer, non-ventilatory
Device class
Class I
Regulation number
868.5640
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
VAX300
GUDID
IPN922102

Related devices

Category: Atomizer, non-ventilatory

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

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See all devices from Teleflex Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)