Identity
- Device Name
- Short Engine Blade EUDAMED
- Model / Reference
- SEBC EUDAMEDSEB-U(BS) EUDAMEDSEB-U2(BS) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800099072061 EUDAMED08800099071903 EUDAMED08800099071897 EUDAMED
- Basic UDI-DI
- 88000990SEBZ8 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Short Engine Blade by BioMaterials Korea, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000990SEBZ8 | Class I | Active |
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Manufacturer
- Manufacturer
- BioMaterials Korea, Inc.
- EUDAMED SRN
- KR-MF-000019882
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (3)
- EUDAMED 038b4bc8-ac43-4dce-9d9c-db7c263f2ad8 61 fields · synced Jul 23, 2026
- EUDAMED b705176d-cde2-46fd-9610-967b3be2377d 61 fields · synced May 19, 2026
- EUDAMED d3a9850f-f2cc-422a-8bd1-9b01ec934e67 61 fields · synced May 19, 2026