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Single Use Cleaning Brush

by Yangzhou Fartley Medical Instrument Technology Co., Ltd. EUDAMEDGUDID

Active European Union

Ref K20000018

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69709008510017P Basic UDI-DIDate17 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06936603227947 UDI-DIDate7 Jul 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • 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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Surgical instrument/endoscope cleaning utensil, single-use
Device Name
Disposable Cleaning Brushes
Model / Ref / Catalog
K20000018, FTL-CB-EBA
Primary DI / UDI-DI
06936603227947
Basic UDI-DI
69709008510017P
Direct Marketing DI
06936603227947
FDA Product Code
MNL
EMDN Code
Z12011385 Cleaning, disinfection and sterilisation instruments - consumables
GMDN Term
Surgical instrument/endoscope cleaning utensil, single-use
Device Class
Class I
Regulation Number
876.1500
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
K20000018
GUDID
FTL-CB-EBA

Manufacturer details

EUDAMED SRN
CN-MF-000009371
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Yangzhou Fartley Medical Instrument Technology Co., Ltd

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: 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
  • Serial Number: No
  • Manufacturing Date: No