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Xiaokang

by Shandong Xiaokang Biotechnology Co., Ltd. China EUDAMED

Model 17.5*9.5cm;14.5*9cm EMDN T020604

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69415623MASK01MW Basic UDI-DIDate1 Nov 2022RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Disposable Medical Mask
Model / Reference
17.5*9.5cm, 14.5*9cm
Primary DI / UDI-DI
06941562301010
Basic UDI-DI
69415623MASK01MW
EMDN Code
T020604 Medical use face masks, type ii and iir
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000011678
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shandong Xiaokang Biotechnology Co., Ltd.

See all devices from Shandong Xiaokang Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED c42e2669-4012-4864-84f4-b628cef5816b 61 fields · synced 22 Oct 2026