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Hudson Rci IPN044038

by Teleflex Incorporated

Ref 22542

Hudson Rci IPN044038 (22542) is a device classified as Class IIa in the EU and Class I in the US made by Teleflex Incorporated, registered in EUDAMED on 21 Jul 2026 (Basic UDI-DI B-04026704388844) and listed in FDA GUDID since 30 Jul 2025 (UDI-DI 04026704388844), active as of 24 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04026704388844 Basic UDI-DI 04026704388844UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026704388844 UDI-DI Date30 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04026704388844 registered 21 Jul 2026 Active
  • FDA GUDID UDI-DI 04026704388844 listed 30 Jul 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04026704388844
  2. Registered EUDAMED B-04026704388844

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  • Withdrawn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
Expandi-Flex with Elbow EUDAMED
Hudson Rci GUDID
Generic name
Breathing circuit catheter mount, single-use
Device name
Catheter Mount
Model / Ref / Catalog
22542, IPN044038
Primary DI / UDI-DI
04026704388844
Basic UDI-DI
B-04026704388844
FDA product code
BZO
EMDN code
R020299 Mount catheters - other
GMDN term
Breathing circuit catheter mount, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5975
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
22542
GUDID
IPN044038
Device classEUDAMED
Class IIa
GUDID
Class I
Supplied sterileEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 04026704388844: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Breathing circuit catheter mount, single-use

Similar devices in this category

Other devices filed under MOUNT CATHETERS - OTHER.

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    Class II

  • Arrow IPNB00826 Open recall

    Class II

  • Arrow IPNB00822 Open recall

    Class II

  • Arrow IPNB00827 Open recall

    Class II

See all devices from Teleflex Incorporated →

Properties

  • Supplied sterile NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)