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CholangioFlex™ N

by Mauna Kea Technologies France EUDAMEDGUDID

Ref FP-10035Model CholangioFlex™N

Product code OWNEMDN Z12020585

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-03760187912073 Basic UDI-DIDate14 Jan 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-03760187912073 Basic UDI-DIDate14 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760187912073 UDI-DIDate15 May 2020ListedStatusIn distribution

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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Confocal endomicroscopy system probe
Device Name
CholangioFlex™N
Model / Reference
CholangioFlex™N, FP-10035
Primary DI / UDI-DI
03760187912073
Basic UDI-DI
B-03760187912073, 376018791NCM1DV
Direct Marketing DI
03760187912073
510(k) Number
FDA Product Code
OWN
EMDN Code
Z12020585 Upper gastrointestinal tract endoscopy instruments - consumables
GMDN Term
Confocal endomicroscopy system probe
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
Market of Registration
France
Commercial Distribution
In Commercial Distribution
Sterilization Method
High-level Disinfectant

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000000835

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Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
  • Expiration Date
  • 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
  • Lot / Batch Number: No

Sources (3)

  • EUDAMED bbafb58c-c923-416c-a11b-04400633ffa5 61 fields · synced 22 Oct 2026
  • EUDAMED 03760187912073|376018791NCM1DV 61 fields · synced 19 May 2026
  • FDA UDI 8d8baf69-9499-4e75-b4a2-6a325daa4d45 34 fields · synced 30 May 2026