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Instrument Tray APTUS CCS 4.0, Upper

by Medartis AG 2 variants

Ref A-6603.442, A-6603.445

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300378000NY Basic UDI-DI Date22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630037849575 UDI-DI Date10 Apr 2024ListedStatusListed GUDID: in commercial distribution

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

1 recall · 1 ongoing · FDA

    • Ongoing Z-2361-2026 FDA Class II initiated 24 Apr 2026

    The cannulation of the CCS screw is not centered.

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  • Withdrawn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
Instrument Tray APTUS CCS 4.0, Upper EUDAMED
Aptus GUDID
Generic Name
Device sterilization/disinfection container, reusable
Device Name
Container
Model / Ref / Catalog
A-6603.442, A-6603.445
Primary DI / UDI-DI
07630037849575, 07630894811173
Basic UDI-DI
76300378000NY
510(k) Number
FDA Product Code
HWC, KCT
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, 880.6850
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CH-MF-000022291
Authorised representative
Medartis GmbH DE-AR-000005810

Related devices

Category: Device sterilization/disinfection container, reusable

Other devices from Medartis AG

See all devices from Medartis AG →

Properties

  • Prescription Use NoGUDIDYesGUDID
  • Lot / Batch Number NoGUDIDYesGUDID
  • Serial Number YesGUDIDNoGUDID
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No