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Keewell

by Keewell Medical Technology Co., Ltd China EUDAMED

Ref FT1800Model QW618, FT2800, FT2811, FT2855, FT1800, FT800, FT70

EMDN Z12040208

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69542183QH004MF Basic UDI-DIDate19 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Blood and Infusion Warmers
Model / Reference
QW618, FT2800, FT2811, FT2855, FT1800, FT800, FT70
Primary DI / UDI-DI
06954218301203
Basic UDI-DI
69542183QH004MF
EMDN Code
Z12040208 Body thermoregulation equipment
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000016265
Authorised representative
Wellita International BV BE-AR-000010384

Other devices from Keewell Medical Technology Co., Ltd

See all devices from Keewell Medical Technology Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 06954218301203|69542183QH004MF 61 fields · synced 23 Oct 2026