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Maxillary Skeletal Expander

by BioMaterials Korea, Inc. 25 variants

Ref KBE Ⅱ-8-001Model KBE Ⅱ - type

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800099060860 Basic UDI-DI 08800099060860UDI-DIDate5 Feb 2025RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Kbe Ⅱ-8
Model / Reference
KBE Ⅱ - type, KBE Ⅱ-8-001
Primary DI / UDI-DI
08800099060860
Basic UDI-DI
B-08800099060860
EMDN Code
Q01020604 Orthodontic dental prostheses
Device Class
Class IIa
EU market of registration
Spain

Manufacturer details

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

Related devices

Category: Dental appliance fabrication material, ceramic

Other devices from BioMaterials Korea, Inc.

See all devices from BioMaterials Korea, Inc. →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No