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INT, K2 Microcatheter MCS02-6

by Shanghai Kindly Medical Instruments Co., Ltd. EUDAMEDGUDID

Active European Union

Ref MCS02-6Model MCM01, MCM02, MCM03, MCM04, MCS01, MCS02, MCS03, MCS04

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69509009CEMCRS Basic UDI-DIDate24 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06950900955709 UDI-DIDate29 Aug 2023ListedStatusListed 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  • Withdrawn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

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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
INT,K2 Microcatheter
Generic Name
Coronary artery infusion catheter
Device Name
Micro Catheter
Model / Reference
MCS02-6, MCM01, MCM02, MCM03, MCM04, MCS01, MCS02, MCS03, MCS04
Primary DI / UDI-DI
06950900955709
Basic UDI-DI
69509009CEMCRS
510(k) Number
FDA Product Code
DQY
EMDN Code
C0104020101 Panoramic and selective peripheral diagnostic angiography catheters and microcatheters
GMDN Term
Coronary artery infusion catheter
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1250
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K201706)

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Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No