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Disposable Medical Mask

by Jiangsu SonaCare Medical Science & Technology Co., Ltd. China EUDAMED

Ref Earloop Type BModel Earloop TypeA; Binding Belt Type A Earloop Type B; Binding Belt Type B EMDN T020604

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697031425MedicalMaskXN Basic UDI-DIDate2 Apr 2025RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Device Name
Disposable Medical Mask
Model / Reference
Earloop TypeA, Binding Belt Type A Earloop Type B, Binding Belt Type B, Earloop Type B
Primary DI / UDI-DI
16970314254998
Basic UDI-DI
697031425MedicalMaskXN
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-000003165
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Jiangsu SonaCare Medical Science & Technology 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 9649018f-5ab0-4ab4-a6d8-2247c1d3c363 61 fields · synced 24 Oct 2026