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Long Engine Blade
EUDAMEDClass I (EU MDR)
Ref LEBO-MPRef LEB-U2(BS)Ref LEB-SMSRef LEBC
Identity
- Device Name
- Long Engine Blade EUDAMED
- Model / Reference
- LEBO-MP EUDAMEDLEB-U2(BS) EUDAMEDLEB-SMS EUDAMEDLEBC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800099072054 EUDAMED08800099071934 EUDAMED08800099072009 EUDAMED08800099072115 EUDAMED
- Basic UDI-DI
- 88000990LEBY5 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
Long 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 | 88000990LEBY5 | 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 (4)
- EUDAMED 7d233bb5-b693-458b-9c3c-1ce388095808 61 fields · synced Jul 25, 2026
- EUDAMED cf4d1baa-37ee-4417-8db8-b9fd5ffc7aa7 61 fields · synced May 17, 2026
- EUDAMED aee0cc5f-339e-4325-b1d2-3c12f0daf0ed 61 fields · synced May 17, 2026
- EUDAMED 4ddeb158-523b-4261-98fe-3b32b392282f 61 fields · synced May 18, 2026