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Medical Face Mask

by ESound Medical Device Co., Ltd. EUDAMED

Active European Union

Ref REF1055Model "Pianar(Surgical Face Mask)：Large Size:17.5*9.5cm Middle Size:14.5*9.5cm Folded(Medical Protective Mask)"

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697018430FaceMask6Q Basic UDI-DIDate22 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Medical Face Mask
Model / Reference
"Pianar(Surgical Face Mask)：Large Size:17.5*9.5cm Middle Size:14.5*9.5cm Folded(Medical Protective Mask)", REF1055
Primary DI / UDI-DI
06979972415218
Basic UDI-DI
697018430FaceMask6Q
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
CN-MF-000015376
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from ESound Medical Device Co., Ltd.

Properties

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