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uCentum

by Ulrich GmbH & Co. KG 41 variants

Ref CS 3890-032-002Model Layer

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04052536220755 UDI-DI Date19 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4052536000226Q8 Basic UDI-DI 04052536220755UDI-DIDate13 Jun 2025RegisteredStatusActive

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 · FDA

    • Terminated Z-1126-2019 FDA Class II initiated 8 Mar 2019 on shared 510(k) K123717

    Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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

Generic Name
Device sterilization/disinfection container, reusable
Model / Reference
Layer, CS 3890-032-002
Primary DI / UDI-DI
04052536220755
Basic UDI-DI
4052536000226Q8
510(k) Number
FDA Product Code
MNH, MNI, NKB
EMDN Code
V0402 Clinical use trays and bowls
GMDN Term
Device sterilization/disinfection container, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3070
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
DE-MF-000006411

Other devices from ulrich GmbH & Co. KG

See all devices from ulrich GmbH & Co. KG →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Serial Number: No
  • Expiration Date: No