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Cs 3850-03

by Ulrich GmbH & Co. KG

Ref CS 3850-03Model Handle for adapter for injection

Cs 3850-03 is a device classified as Class I in the EU and Class II in the US made by Ulrich GmbH & Co. KG, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 4052536000535QQ), cleared under FDA 510(k) K123717 on 4 Mar 2013 and listed in FDA GUDID since 30 Jul 2016 (UDI-DI 04052536081684), active as of 7 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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123717

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4052536000535QQ Basic UDI-DI 04052536081684UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04052536081684 UDI-DI Date30 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK123717 Date4 Mar 2013IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4052536000535QQ registered 6 Nov 2026 Active
  • FDA 510(k) K123717 decided 4 Mar 2013 Active
  • FDA GUDID UDI-DI 04052536081684 listed 30 Jul 2016 Listed

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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K123717
  2. Listed FDA GUDID 04052536081684
  3. Recall initiated FDA recalls Z-1126-2019
  4. Registered EUDAMED 4052536000535QQ

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  • Withdrawn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
uCentum
Generic name
General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog
CS 3850-03, Handle for adapter for injection
Primary DI / UDI-DI
04052536081684
Basic UDI-DI
4052536000535QQ
510(k) Number
FDA product code
MNI, MNH, NKB
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3070
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

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.

Related devices

Category: General internal orthopaedic fixation system implantation kit

Cleared under the same submission (K123717)

and 8 more cleared under K123717

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Ulrich GmbH & Co. KG

See all devices from Ulrich GmbH & Co. KG →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)