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Instant Cold Pack

by Koolcare Technology Co., Ltd. 4 variants

Ref KK-II-B200Model 60g, 80g,82g,90g, 98g,100g, 102g,120g, 130g, 140g, 150g, 160g, 170g, 180g, 190g,198g,200g, 202g, 204g,205g, 220g, 230g, 240g, 250g, 260g, 280g, 300g, 302g,320g, 330g, 350g, 400g

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 Number697650729IIBU7 Basic UDI-DI Date22 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  • Withdrawn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
Instant Cold Pack
Model / Reference
60g, 80g, 82g, 90g, 98g, 100g, 102g, 120g, 130g, 140g, 150g, 160g, 170g, 180g, 190g, 198g, 200g, 202g, 204g, 205g, 220g, 230g, 240g, 250g, 260g, 280g, 300g, 302g, 320g, 330g, 350g, 400g, KK-II-B200
Primary DI / UDI-DI
06976507291026, 06976507291019
Basic UDI-DI
697650729IIBU7
Direct Marketing DI
06976507291026
EMDN Code
M9001 Cryotherapy and thermotherapy devices
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