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Neonatal Dual Heated Wire Breathing System with Autofill Chamber 038-03-356U

by Flexicare Medical Limited

Ref 038-03-356U

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-05055788709640 Basic UDI-DI 05055788709640UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055788709640 UDI-DI Date11 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  • Withdrawn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
Neonatal Dual Heated Wire Breathing System with Autofill Chamber
Generic Name
Ventilator breathing circuit, single-use
Device Name
Humidification Circuits
Model / Reference
038-03-356U
Primary DI / UDI-DI
05055788709640
Basic UDI-DI
B-05055788709640
FDA Product Code
BTT, BZE
EMDN Code
R020107 Thermoregulated breathing circuits
GMDN Term
Ventilator breathing circuit, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5450, 868.5270
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: Ventilator breathing circuit, single-use

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No