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9736632

by Case Medical Inc

Part of a family of 35 devices: see the family page

Ref 9736632Model SteriTite

9736632 is a device classified as Class I in the EU and Class II in the US made by Case Medical Inc, registered in EUDAMED on 29 Jun 2026 (Basic UDI-DI 0653159SC0004SAR), cleared under FDA 510(k) K240898 on 31 Jul 2024 and listed in FDA GUDID since 20 Mar 2026 (UDI-DI 00653159015182), 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) K240898

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 Number0653159SC0004SAR Basic UDI-DI 00653159015182UDI-DIDate29 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00653159015182 UDI-DI Date20 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK240898 Date31 Jul 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0653159SC0004SAR registered 29 Jun 2026 Active
  • FDA 510(k) K240898 decided 31 Jul 2024 Active
  • FDA GUDID UDI-DI 00653159015182 listed 20 Mar 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K240898
  2. Listed FDA GUDID 00653159015182
  3. Registered EUDAMED 0653159SC0004SAR

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  • Withdrawn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

Trade name
9736632 EUDAMED
Case Medical GUDID
Generic name
Device sterilization/disinfection container, reusable
Device name
9736523
Model / Ref / Catalog
SteriTite, 9736632
Primary DI / UDI-DI
00653159015182
Basic UDI-DI
0653159SC0004SAR
Direct marketing DI
00653159015182
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
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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-000036357
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under CONTAINERS FOR STERILISATION.

Other devices from Case Medical Inc

See all devices from Case Medical Inc →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (23, all answered No)