Maxillary Skeletal Expander
by BioMaterials Korea, Inc. South Korea EUDAMED
Ref KBE Ⅱ-10-001Model KBE Ⅱ - type EMDN Q01020604
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08800099060877 | Date5 Feb 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Device Name
- Kbe Ⅱ-10
- Model / Reference
- KBE Ⅱ - type, KBE Ⅱ-10-001
- Primary DI / UDI-DI
- 08800099060877
- Basic UDI-DI
- B-08800099060877
- EMDN Code
- Q01020604 Orthodontic dental prostheses
- Device Class
- Class IIa
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- KR-MF-000019882
- Authorised representative
- KTR Europe GmbH DE-AR-000005685
Other devices from BioMaterials Korea, Inc.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED d450a7cd-dd04-4ee4-93ef-2f7e50ba70b9