Skip to content

Blade for CMF Surgery

by BioMaterials Korea, Inc. 20 variants

Ref LEB-20C

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000990CSBY2 Basic UDI-DI 08800099071477UDI-DIDate27 Nov 2024RegisteredStatusActive

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  • Withdrawn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

Device Name
Blade for CMF Surgery
Model / Reference
LEB-20C
Primary DI / UDI-DI
08800099071477
Basic UDI-DI
88000990CSBY2
EMDN Code
Q010599 Dental instruments, single-use - other
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
KR-MF-000019882
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from BioMaterials Korea, Inc.

See all devices from BioMaterials Korea, Inc. →

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