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Maxineb Duo Filter 032-10-035U

by Flexicare Medical Limited EUDAMEDGUDID

Active European Union

Ref 032-10-035U

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055931102038 Basic UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055931102038 UDI-DIDate27 Mar 2020ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Maxineb Duo Filter
Generic Name
Therapeutic agent nebulizer, benchtop
Device Name
Nebulisers
Model / Reference
032-10-035U
Primary DI / UDI-DI
05055931102038
Basic UDI-DI
B-05055931102038
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
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

See all devices from Flexicare Medical Limited →

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