Skip to content

Disposable Heat and Moisture Exchanger Filters

by Ningbo Huakun Medical Equipment Co., Ltd. EUDAMED

Active European Union

Ref J1A 3163Model HMEF1

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69418508HMEF1R5 Basic UDI-DIDate9 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
HMEF1, J1A 3163
Primary DI / UDI-DI
06941850828588
Basic UDI-DI
69418508HMEF1R5
EMDN Code
R040199 Ventilation filters - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

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

Related devices

Category: Microbial medical gas filter, single-use

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

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

Properties

  • Sterile

Other properties (12)

  • 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