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Lead Glasses, Lead Goggles, X-Ray Lead Glasses, X-Ray Lead Goggles, X-Ray Protection Lead Glasses, X-Ray Protection Lead Goggles, Protective Mask, Protective Eyes Shield

by Longkou Longyue Medical Device Co., Ltd

Ref FC13, FC13-2, FC13-4, FC13-5, FC13-6, FC13-7, FC13-8, FC13-9, FC13-10, FA15, FA15-1

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697619086FEYEPROTECTIONZG Basic UDI-DI 01697619086052UDI-DIDate30 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
FC13, FC13-2, FC13-4, FC13-5, FC13-6, FC13-7, FC13-8, FC13-9, FC13-10, FA15, FA15-1
Primary DI / UDI-DI
01697619086052
Basic UDI-DI
697619086FEYEPROTECTIONZG
EMDN Code
T030405 Radiotherapy eye protection
Device Class
Class I
EU market of registration
Bulgaria

Manufacturer details

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

Other devices from Longkou Longyue 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