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COOLIEF* SINERGY* Cooled Radiofrequency Kit Advanced

by Avanos Medical, Inc. 2 variants

Ref 120006190Model SIKA-17

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0193493SIKA00059SY Basic UDI-DI 00193493001453UDI-DIDate13 Aug 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
COOLIEF* SINERGY* Cooled Radiofrequency Kit Advanced
Model / Reference
SIKA-17, 120006190
Primary DI / UDI-DI
00193493001453
Basic UDI-DI
0193493SIKA00059SY
EMDN Code
K020399 Devices for surgery with radiofrequency generator, single-use - other
Device Class
Class IIb
Medical Purpose
The SINERGY 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

  • Sterile