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Hu-Friedy

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

Part of a family of 31 devices: see the family page

Ref IMDINCO2MModel Sterilization Packaging

Hu-Friedy (IMDINCO2M) is a device classified as Class I in the EU and Class II in the US made by Hu-Friedy Manufacturing Co., LLC, registered in EUDAMED on 8 Aug 2025 (Basic UDI-DI 0889950IMSSterilizationUG), cleared under FDA 510(k) K123234 on 5 Jul 2013 and listed in FDA GUDID since 30 May 2017 (UDI-DI 10889950035488), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123234

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0889950IMSSterilizationUG Basic UDI-DI 10889950035488UDI-DIDate8 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10889950035488 UDI-DI Date30 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123234 Date5 Jul 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0889950IMSSterilizationUG registered 8 Aug 2025 Active
  • FDA 510(k) K123234 decided 5 Jul 2013 Active
  • FDA GUDID UDI-DI 10889950035488 listed 30 May 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K123234
  2. Listed FDA GUDID 10889950035488
  3. Registered EUDAMED 0889950IMSSterilizationUG

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Device sterilization/disinfection container, reusable
Model / Ref / Catalog
Sterilization Packaging, IMDINCO2M
Primary DI / UDI-DI
10889950035488
Basic UDI-DI
0889950IMSSterilizationUG
510(k) Number
FDA product code
KCT
EMDN code
S010499 Sterilisation containers - other
GMDN term
Device sterilization/disinfection container, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6850
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

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

  • Sterilise before use UDI-DI 10889950035488: EUDAMED states No, FDA GUDID states Yes.

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

Manufacturer details

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

Similar devices in this category

Other devices filed under CONTAINERS FOR STERILISATION.

Other devices from Hu-Friedy Manufacturing Co., LLC

See all devices from Hu-Friedy Manufacturing Co., LLC →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)