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Xs-FiL B1

by B&E KOREA Co., Ltd. EUDAMED

Active European Union

Ref #1111B1

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000353B&ECompositeLCEU Basic UDI-DIDate8 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Xs-FiL
Model / Reference
#1111B1
Primary DI / UDI-DI
08800035302238
Basic UDI-DI
88000353B&ECompositeLCEU
EMDN Code
Q01010103 Dental restorative composites
Device Class
Class IIa
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
KR-MF-000030252
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from B&E KOREA Co., Ltd.

See all devices from B&E KOREA 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