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Protective Mask, Faceshield With X-Ray Radiation Protective, X-Ray Protective Mask, X-Ray Protective Faceshield, Lead Face Mask, X-Ray Lead Face Mask, X-Ray Protective Lead Face Mask

by Longkou Longyue Medical Device Co., Ltd China EUDAMED

Ref FD11, FD12, FA15

EMDN T030401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697619086FMASKSV9 Basic UDI-DIDate30 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
FD11, FD12, FA15
Primary DI / UDI-DI
01697619086069
Basic UDI-DI
697619086FMASKSV9
EMDN Code
T030401 Radiotherapy protection masks
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000039625
Authorised representative
Share info GmbH DE-AR-000005132

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 1a31c9bd-bfe7-4d24-ad49-3bd20e02f70d 61 fields · synced 22 Oct 2026