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InfuseOne 42357-01H

by Ethox Medical, LLC

Ref 42357‐01HModel Pressure Infusion Bags

InfuseOne 42357-01H is a Class I device made by Ethox Medical, LLC, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI B-10889483230787) and listed in FDA GUDID since 1 Jul 2024 (UDI-DI 10889483230787), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10889483230787 Basic UDI-DI 10889483230787UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10889483230787 UDI-DI Date1 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10889483230787 registered 16 Oct 2026 Active
  • FDA GUDID UDI-DI 10889483230787 listed 1 Jul 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10889483230787
  2. Registered EUDAMED B-10889483230787

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  • Withdrawn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
InfuseOne, 3000 mL Pressure Infuser w/hook EUDAMED
InfuseOne GUDID
Generic name
Intravenous pressure infusor, manual, reusable
Model / Ref / Catalog
Pressure Infusion Bags EUDAMED
42357‐01H EUDAMED
42357-01H GUDID
Primary DI / UDI-DI
10889483230787
Basic UDI-DI
B-10889483230787
FDA product code
KZD
EMDN code
A0599 Mechanical infusion systems, single-use - other
GMDN term
Intravenous pressure infusor, manual, reusable
Device class
Class I
Regulation number
880.5420
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Pressure Infusion Bags
42357‐01H
GUDID
42357-01H

Related devices

Category: Intravenous pressure infusor, manual, reusable

Similar devices in this category

Other devices filed under MECHANICAL INFUSION SYSTEMS, SINGLE-USE.

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Properties

  • Measuring function
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)