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Heated humidifiers

by Ningbo Huakun Medical Equipment Co., Ltd. China EUDAMED

Ref HK-D100Model HK-H100，HK-D100

EMDN R060201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697350401H1009X Basic UDI-DIDate11 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
HK-H100，HK-D100, HK-D100
Primary DI / UDI-DI
06973504019998
Basic UDI-DI
697350401H1009X
Direct Marketing DI
06973504019998
EMDN Code
R060201 Active ventilation humidification systems,
Device Class
Class IIb
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000008459
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Ningbo Huakun Medical Equipment Co., Ltd.

See all devices from Ningbo Huakun Medical Equipment Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 06973504019998|697350401H1009X 61 fields · synced 25 Oct 2026