Skip to content

Aptus A-6603.034

by Medartis Inc.

Ref A-6603.034

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232251

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300378000NY Basic UDI-DI 07630894811081UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630894811081 UDI-DI Date10 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK232251 Date3 Nov 2023DecidedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Case CCS 2.2, 3.0, Add-On Foot EUDAMED
Aptus GUDID
Generic name
Device sterilization/disinfection container, reusable
Device name
Container
Model / Ref / Catalog
A-6603.034
Primary DI / UDI-DI
07630894811081
Basic UDI-DI
76300378000NY
510(k) Number
FDA product code
HWC
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Device sterilization/disinfection container, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3040
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 · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Related devices

Category: Device sterilization/disinfection container, reusable

Cleared under the same submission (K232251)

Show all (12)

Other devices from Medartis Inc.

  • Avenger M70HC018

    Class II

  • Avenger M70HC020

    Class II

  • Avenger M70HC022

    Class II

  • Avenger M70HC024

    Class II

  • Avenger M70HC118

    Class II

  • Avenger M70HC120

    Class II

See all devices from Medartis Inc. →

Properties

  • Sterilise before use
  • Serial number
  • Manufacturing date

Other properties (22)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Expiration date: No