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Hudson RCI

by Medline Industries, LP United States EUDAMED510(k)

Ref 1650CE, 3230CE, 1770CE, 2555CE510(k) K234032

Product code BZEEMDN R028003

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0888277DC357NSLD Basic UDI-DIDate14 Mar 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK234032 Date4 Jun 2024ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

Device Name
Hudson RCI Water Trap
Hudson RCI Disposable Non-Prefilled Humidifiers
Hudson RCI Variable Concentration Empty Large Volume Nebulizer
Hudson RCI Oxygen Tubing Connector Hudson RCI Oxygen Tubing Adaptor Hudson RCI Trach Tee Oxygenator Hudson RCI Nipple and Nut Adaptor
Model / Reference
1650CE, 3230CE, 1770CE, 2555CE
Primary DI / UDI-DI
00888277447243, 00888277445966, 00888277445980, 40888277447043
Basic UDI-DI
0888277DC357NSLD, 0888277DC348NSLB, 0888277DC351NSKF, 0888277DC349NSOXV8
Unit of Use DI
10888277447042
510(k) Number
FDA Product Code
BZE
EMDN Code
R028003, R060202, R060101, R020302
Device Class
Class I EUDAMED
Class IIa EUDAMED
Class IIb EUDAMED
Class II 510(k)
Regulation
21 CFR Part 868.5270
Market of Registration
Netherlands
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class I
Class IIa
Class IIb
510(k)
Class II

Manufacturer details

EUDAMED SRN
US-MF-000009717
Authorised representative
Medline International France FR-AR-000001814

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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

Sources (5)

  • EUDAMED 6c22c70b-f1f5-4d0f-bb79-b9b36cd36a27 85 fields · synced 22 Oct 2026
  • EUDAMED 00888277445966|0888277DC348NSLB 61 fields · synced 18 May 2026
  • EUDAMED 00888277445980|0888277DC351NSKF 61 fields · synced 18 May 2026
  • FDA 510(k) K234032 24 fields · synced 18 May 2026
  • EUDAMED 40888277447043|0888277DC349NSOXV8 61 fields · synced 25 Jul 2026