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Maxillary Skeletal Expander
EUDAMEDClass IIa (EU MDR)
Ref KBE-12-001Model KBE I - type
Identity
- Trade Name
- Maxillary Skeletal Expander EUDAMED
- Device Name
- KBE-12 EUDAMED
- Model / Reference
- KBE I - type EUDAMEDKBE-12-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800099060846 EUDAMED
- Basic UDI-DI
- B-08800099060846 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
Maxillary Skeletal Expander by BioMaterials Korea, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800099060846 | Class IIa | Active |
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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 76f70baa-090a-41ca-b9b8-a1dab18c41a2 61 fields · synced Jun 18, 2026