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Maxineb Duo Nebulizer With Pediatric Closed System Mask, Tubing And Filter 032-10-083U

by Flexicare Medical Limited

Ref 032-10-083U

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

CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055931102236 Basic UDI-DI 05055931102236UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055931102236 UDI-DI Date27 Mar 2020ListedStatusListed 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Maxineb Duo Nebulizer With Pediatric Closed System Mask, Tubing And Filter
Generic Name
Therapeutic agent nebulizer, benchtop
Device Name
Nebulisers
Model / Reference
032-10-083U
Primary DI / UDI-DI
05055931102236
Basic UDI-DI
B-05055931102236
FDA Product Code
CAF
EMDN Code
R060101 Cold nebulisation systems
GMDN Term
Therapeutic agent nebulizer, benchtop
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5630
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Therapeutic agent nebulizer, benchtop

Other devices from Flexicare Medical Limited

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Properties

  • Single Use
  • Administering Medicine
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No