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Disposable Bacterial/Viral Filter

by Zhejiang Haisheng Medical Device Co., Ltd. United States EUDAMED

Ref A501-8

EMDN R01058002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06944375390714 Basic UDI-DIDate20 May 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
A501-8
Primary DI / UDI-DI
06944375390714, 06944375303141
Basic UDI-DI
B-06944375390714, B-06944375303141
EMDN Code
R01058002 Tracheostomy filters
Device Class
Class IIa
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000026345
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine NoEUDAMEDYesEUDAMED
Other properties (9)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED 5865a636-bd1a-4757-a749-b36b07353a16 61 fields · synced 22 Oct 2026
  • EUDAMED 06944375303141|B-06944375303141 61 fields · synced 19 May 2026