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COOLIEF* Multi-Cooled Radiofrequency Kit Advanced

by Avanos Medical, Inc. United States EUDAMED

Ref 120006180Model MCKA2-17-100-4, MCKA2-17-150-4, MCKA2-17-50-2, MCKA2-17-50-4, MCKA2-17-75-2, MCKA2-17-75-4, MCKA2-17-75-5.5, MCKA3-17-100-4, MCKA3-17-150-4, MCKA3-17-50-2, MCKA3-17-50-4, MCKA3-17-75-2, MCKA3-17-75-4 EMDN K020399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0193493MCKA00059K4 Basic UDI-DIDate13 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
COOLIEF* Multi-Cooled Radiofrequency Kit Advanced
Model / Reference
MCKA2-17-100-4, MCKA2-17-150-4, MCKA2-17-50-2, MCKA2-17-50-4, MCKA2-17-75-2, MCKA2-17-75-4, MCKA2-17-75-5.5, MCKA3-17-100-4, MCKA3-17-150-4, MCKA3-17-50-2, MCKA3-17-50-4, MCKA3-17-75-2, MCKA3-17-75-4, 120006180
Primary DI / UDI-DI
00193493001354
Basic UDI-DI
0193493MCKA00059K4
EMDN Code
K020399 Devices for surgery with radiofrequency generator, single-use - other
Device Class
Class IIb
Medical Purpose
The Multi-Cooled RF Kit is supplied as a procedure pack in accordance with Article 22 of Regulation (EU) 2017/745, comprising compatible, CE-marked medical devices that are packaged together for use in a defined medical procedure.

Manufacturer details

EUDAMED SRN
US-PR-000052444

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 00193493001354|0193493MCKA00059K4 61 fields · synced 24 Oct 2026