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Disposable Breathing Filter

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

Ref A501-3

EMDN R040101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number694437539004KA Basic UDI-DIDate31 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 6201231CE01 Supplemented

    Quality assurance EU MDR

    Notified body
    Notified body 0344
    Issued
    19 Jun 2026
    Expires
    1 Mar 2030
    Reason
    Add device or group

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
A501-3
Primary DI / UDI-DI
06944375366979
Basic UDI-DI
694437539004KA
EMDN Code
R040101 Antibacterial and antiviral respiratory 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
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 06944375366979|694437539004KA 61 fields · synced 24 Oct 2026