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Cleaning Brush CS-C3S

by PENTAX Medical Corporation EUDAMEDGUDID

Withdrawn No longer placed on the EU market

Ref 6217001Z639SModel See UDI-DI information for model names

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4961333010507YC Basic UDI-DIDate12 Jul 2022RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number04961333070657 UDI-DIDate7 Apr 2017ListedStatusWithdrawn

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

6 recalls · FDA

    • Terminated Z-2875-2016 FDA Class II initiated 31 May 2016

    Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.

  • 2 recalls, same reason

    • Terminated Z-2065-2016 FDA Class II initiated 6 Apr 2016
    • Terminated Z-2076-2016 FDA Class II initiated 6 Apr 2016

    Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

  • 3 recalls, same reason

    • Terminated Z-2325-2017 FDA Class II initiated 11 Jan 2011
    • Terminated Z-2326-2017 FDA Class II initiated 11 Jan 2011
    • Terminated Z-2324-2017 FDA Class II initiated 11 Jan 2011

    This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.

Specification

EUDAMED · GUDID

Trade Name
Cleaning Brush CS-C3S EUDAMED
Pentax GUDID
Generic Name
Surgical instrument/endoscope cleaning utensil, reusable
Device Name
PENTAX Medical Cleaning Brush
Model / Reference
See UDI-DI information for model names EUDAMED
6217001Z639S EUDAMED
CS-C3S GUDID
Primary DI / UDI-DI
04961333070657
Basic UDI-DI
4961333010507YC
FDA Product Code
EOQ
EMDN Code
V070101 Endoscopes cleaning brushes - for generic use
GMDN Term
Surgical instrument/endoscope cleaning utensil, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
874.4680
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
See UDI-DI information for model names
6217001Z639S
GUDID
CS-C3S
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
JP-MF-000005227
Authorised representative
PENTAX Europe GmbH DE-AR-000000006

Other devices from PENTAX Medical Corporation

See all devices from PENTAX Medical Corporation →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • 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
  • Manufacturing Date: No