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Maxillary Skeletal Expander
EUDAMEDClass IIa (EU MDR)
Ref RPE-12-001Model RPE typeRef MSE Ⅱ-10 F-001Model MSE Ⅱ- F typeRef MSE-8-001Model MSE Ⅰ - typeRef MSE-11-001Ref MSE Ⅱ-6 E-001Model MSE Ⅱ- E typeRef MSE Ⅱ-12 F-001Ref KBE Ⅱ-8-001Model KBE Ⅱ - typeRef KBE-8-001Model KBE I - typeRef KBE Ⅱ-12-001Ref KBE Ⅱ-10-001
Identity
- Trade Name
- Maxillary Skeletal Expander EUDAMED
- Device Name
- RPE-12 EUDAMEDMSE Ⅱ-10 F EUDAMEDMSE-8 EUDAMEDmse-11 EUDAMEDMSE Ⅱ-6 E EUDAMEDMSE Ⅱ-12 F EUDAMEDKBE Ⅱ-8 EUDAMEDKBE-8 EUDAMEDKBE Ⅱ-12 EUDAMEDKBE Ⅱ-10 EUDAMED
- Model / Reference
- RPE type EUDAMEDRPE-12-001 EUDAMEDMSE Ⅱ- F type EUDAMEDMSE Ⅱ-10 F-001 EUDAMEDMSE Ⅰ - type EUDAMEDMSE-8-001 EUDAMEDMSE-11-001 EUDAMEDMSE Ⅱ- E type EUDAMEDMSE Ⅱ-6 E-001 EUDAMEDMSE Ⅱ-12 F-001 EUDAMEDKBE Ⅱ - type EUDAMEDKBE Ⅱ-8-001 EUDAMEDKBE I - type EUDAMEDKBE-8-001 EUDAMEDKBE Ⅱ-12-001 EUDAMEDKBE Ⅱ-10-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800099060921 EUDAMED08800099060792 EUDAMED08800099060709 EUDAMED08800099999849 EUDAMED08800099060730 EUDAMED08800099060808 EUDAMED08800099060860 EUDAMED08800099060822 EUDAMED08800099060884 EUDAMED08800099060877 EUDAMED
- Basic UDI-DI
- B-08800099060921 EUDAMEDB-08800099060792 EUDAMEDB-08800099060709 EUDAMEDB-08800099999849 EUDAMEDB-08800099060730 EUDAMEDB-08800099060808 EUDAMEDB-08800099060860 EUDAMEDB-08800099060822 EUDAMEDB-08800099060884 EUDAMEDB-08800099060877 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800099060921 | 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 (10)
- EUDAMED dae9ab45-538e-4bd2-ad3e-33edd77fc8b1 61 fields · synced Sep 18, 2026
- EUDAMED 113389e0-b63c-4274-b21b-f06d6f9b1ee0 61 fields · synced May 17, 2026
- EUDAMED 31b81548-44e3-4bc3-8079-d2b4974e1d87 61 fields · synced May 17, 2026
- EUDAMED a6cdf7ee-208d-469e-b8f5-c068a58f09d1 61 fields · synced May 17, 2026
- EUDAMED 11acaa6f-8d07-421f-b8eb-a53a4f60b356 61 fields · synced May 18, 2026
- EUDAMED 0464dd91-fa1b-402c-a437-87b6884a1bf2 61 fields · synced May 18, 2026
- EUDAMED 5300ddba-a115-4511-afe8-a92dc7a00cfb 61 fields · synced May 18, 2026
- EUDAMED 338bd844-a456-4a93-ac58-85874c8ae84f 61 fields · synced May 18, 2026
- EUDAMED c567cc87-3277-4ff8-bf69-0e90fdc3c9d4 61 fields · synced May 18, 2026
- EUDAMED d450a7cd-dd04-4ee4-93ef-2f7e50ba70b9 61 fields · synced May 18, 2026