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ThermoShield Neonatal Bacterial Viral Filter and HME with Luer Port 038-43-355U

by Flexicare Medical Limited

Ref 038-43-355U

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055788770244 Basic UDI-DI 05055788770244UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055788770244 UDI-DI Date12 Feb 2018ListedStatusListed 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  • Withdrawn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
Flexicare EUDAMED
ThermoShield Neonatal Bacterial Viral Filter and HME with Luer Port GUDID
Generic Name
Heat/moisture exchanger/microbial medical gas filter
Device Name
Filters - Heat and Moisture Exchangers
Model / Reference
038-43-355U
Primary DI / UDI-DI
05055788770244
Basic UDI-DI
B-05055788770244
FDA Product Code
CAH
EMDN Code
R040201 Tracheostomy humidifiers
GMDN Term
Heat/moisture exchanger/microbial medical gas filter
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5260
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: Heat/moisture exchanger/microbial medical gas filter

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • 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
  • Administering Medicine: 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