Skip to content

Sterilization Cassette

by Alliedstar Medical Equipment Co., Ltd.

Ref 6583590Model CASS-1

Sterilization Cassette (6583590) is a device sterilization/disinfection container (EU MDR Class I; FDA Class II; FDA product code KCT, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories) made by Alliedstar Medical Equipment Co., Ltd., cleared under FDA 510(k) K262042 on 14 Oct 2026, registered in EUDAMED on 30 Mar 2026 (Basic UDI-DI 697399344alliedstar03SQ) and listed in FDA GUDID since 26 Oct 2026 (UDI-DI 06973993446022), active as of 9 Nov 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 9 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K262042

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06973993446022 UDI-DI Date26 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK262042 Date14 Oct 2026DecidedStatusActive
European UnionCE/MDR EUDAMED Number697399344alliedstar03SQ Basic UDI-DI Date30 Mar 2026RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K262042 decided 14 Oct 2026 Active
  • EUDAMED Basic UDI-DI 697399344alliedstar03SQ registered 30 Mar 2026 Active
  • FDA GUDID UDI-DI 06973993446022 listed 26 Oct 2026 Listed

Timeline

3 dated events

  1. Registered EUDAMED 697399344alliedstar03SQ
  2. Cleared FDA 510(k) K262042
  3. Listed FDA GUDID 06973993446022

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  • Withdrawn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 / reference
CASS-1, 6583590
Primary DI / UDI-DI
06973993446022, 06973993446039
Basic UDI-DI
697399344alliedstar03SQ
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
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

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

Registry differences

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

  • Sterilise before use UDI-DI 06973993446022: EUDAMED states Yes, FDA GUDID states No.

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
CN-MF-000008845
Authorised representative
Etkon GmbH DE-AR-000009335

Similar devices in this category

Other devices filed under CONTAINERS FOR STERILISATION.

Other devices from Alliedstar Medical Equipment Co., Ltd.

See all devices from Alliedstar Medical Equipment Co., Ltd. →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)