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Maxillary Skeletal Expander

EUDAMED

Class IIa (EU MDR)

Ref KBE-6-001Model KBE I - type

by BioMaterials Korea, Inc.

Identity

Trade Name: Maxillary Skeletal Expander EUDAMED
Device Name: KBE-6 EUDAMED
Model / Reference: KBE I - type EUDAMED
KBE-6-001 EUDAMED

Identifiers

Primary DI / UDI-DI: 08800099060815 EUDAMED
Basic UDI-DI: B-08800099060815 EUDAMED
EMDN Code: Q01020604 ORTHODONTIC DENTAL PROSTHESES EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Dental appliance fabrication material, ceramic

Maxillary Skeletal Expander by BioMaterials Korea, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer: BioMaterials Korea, Inc.
EUDAMED SRN: KR-MF-000019882
Authorised Representative: KTR Europe GmbH DE-AR-000005685

Sources (1)

EUDAMED 40b0a467-d5c0-404a-b5d9-b9e3c450dad1 61 fields · synced Jun 19, 2026