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COOLIEF* Cooled Radiofrequency Kit Advanced

by Avanos Medical, Inc. United States EUDAMED

Ref 120006167Model CRKA-17-100-4, CRKA-17-150-4, CRKA-17-50-2, CRKA-17-50-4, CRKA-17-75-4, CRKA-17-75-5.5 EMDN K020399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0193493CRKA00059LT 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  • Withdrawn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 25 Oct 2026

Device Name
COOLIEF* Cooled Radiofrequency Kit Advanced
Model / Reference
CRKA-17-100-4, CRKA-17-150-4, CRKA-17-50-2, CRKA-17-50-4, CRKA-17-75-4, CRKA-17-75-5.5, 120006167
Primary DI / UDI-DI
00193493001262
Basic UDI-DI
0193493CRKA00059LT
EMDN Code
K020399 Devices for surgery with radiofrequency generator, single-use - other
Device Class
Class IIb
Medical Purpose
The 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 00193493001262|0193493CRKA00059LT 61 fields · synced 25 Oct 2026