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Heat Wraps

by Koolcare Technology Co., Ltd. 82 variants

Ref KK-IW-N 45AModel KK-IW-N(40A,45A,70A,50A,49A,48A,55A,44A,42A,30A,36A,25A,39A,34A,62A,60A,65A,72A,82A,75A,80A,120A),KK-IW-N(40C,45C,70C,50C,49C,48C,55C,44C,42C,30C,36C,25C,35C,39C,34C,62C,60C,65C,72C,82C,75C,80C,120C,215C,185C,175C)

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 Number697650729IWN08R6 Basic UDI-DI 06976507292016UDI-DIDate7 Jul 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  • Withdrawn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
Heat Wraps
Model / Reference
KK-IW-N(40A, 45A, 70A, 50A, 49A, 48A, 55A, 44A, 42A, 30A, 36A, 25A, 39A, 34A, 62A, 60A, 65A, 72A, 82A, 75A, 80A, 120A), KK-IW-N(40C, 45C, 70C, 50C, 49C, 48C, 55C, 44C, 42C, 30C, 36C, 25C, 35C, 39C, 34C, 62C, 60C, 65C, 72C, 82C, 75C, 80C, 120C, 215C, 185C, 175C), KK-IW-N 45A
Primary DI / UDI-DI
06976507292016
Basic UDI-DI
697650729IWN08R6
Direct Marketing DI
06976507292016
EMDN Code
Z120602 Physiotherapy equipment
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000024559
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Koolcare Technology Co., Ltd.

See all devices from Koolcare Technology Co., Ltd. →

Properties

Other properties (13)

  • Sterile: 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