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Hu-Friedy

by Hu-Friedy Manufacturing Co., LLC 1,000+ variants

Ref IM4127Model Cassette

Hu-Friedy (IM4127) is a Class I device made by Hu-Friedy Manufacturing Co., LLC, registered in EUDAMED on 8 Aug 2025 (Basic UDI-DI 0889950IMSCasettes1AS) and listed in FDA GUDID since 10 Sep 2020 (UDI-DI 10889950051921), active as of 24 Oct 2026.

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

CE MDR

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/MDR EUDAMED Number0889950IMSCasettes1AS Basic UDI-DI 10889950051921UDI-DIDate8 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10889950051921 UDI-DI Date10 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0889950IMSCasettes1AS registered 8 Aug 2025 Active
  • FDA GUDID UDI-DI 10889950051921 listed 10 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10889950051921
  2. Registered EUDAMED 0889950IMSCasettes1AS

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Hu-Friedy EUDAMED
Ims GUDID
Generic name
Device sterilization/disinfection container, reusable
Model / Ref / Catalog
Cassette, IM4127
Primary DI / UDI-DI
10889950051921
Basic UDI-DI
0889950IMSCasettes1AS
FDA product code
FSM
EMDN code
S010401 Trays, baskets, tubs for sterilisation and their components
GMDN term
Device sterilization/disinfection container, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000017104
Authorised representative
Hu-Friedy Europe LLC & Co. KG DE-AR-000005530

Related devices

Category: Instrument tray, reusable

Similar devices in this category

Other devices filed under TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS.

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Properties

  • Sterilise before use
  • Lot / batch number
Other properties (23, all answered No)