Identity
- Trade Name
- Engine Blade EUDAMED
- Device Name
- Engine Blade EUDAMED
- Model / Reference
- LEB12 EUDAMEDSEB15 EUDAMEDSEB12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800099090805 EUDAMED08800099090997 EUDAMED08800099090980 EUDAMED
- Basic UDI-DI
- 88000990EGBX8 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
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 | 88000990EGBX8 | 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 8460a496-f489-4a64-be3c-b040c175ad14 61 fields · synced Jul 23, 2026
- EUDAMED 948192de-6207-4934-b632-2a679baa19e9 61 fields · synced May 18, 2026
- EUDAMED b38b290c-e564-4163-8db8-6edce7802223 61 fields · synced May 18, 2026