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FCARE Disposable Breathing Filter CATHETER MOUNT

by Shaoxing Undis Medical Technology Co., Ltd China EUDAMED

Ref HMEF-02Model HMEF EMDN R040101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697053133hbfVX Basic UDI-DIDate7 Apr 2024RegisteredStatusActive

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  • Withdrawn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 · synced 23 Oct 2026

Device Name
Disposable Breathing Filter
Model / Reference
HMEF, HMEF-02
Primary DI / UDI-DI
16970531338976
Basic UDI-DI
697053133hbfVX
Direct Marketing DI
16970531338976
EMDN Code
R040101 Antibacterial and antiviral respiratory filters
Device Class
Class IIa
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000002187
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shaoxing Undis Medical Technology Co., Ltd

See all devices from Shaoxing Undis Medical Technology Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 16970531338976|697053133HBFVX 61 fields · synced 23 Oct 2026