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Driver Blade
EUDAMEDClass I (EU MDR)
Ref SDBCRef SDB-SMSRef SDB-U2(BS)Ref SDB-SL
Identity
- Device Name
- Driver Blade EUDAMED
- Model / Reference
- SDBC EUDAMEDSDB-SMS EUDAMEDSDB-U2(BS) EUDAMEDSDB-SL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800099072108 EUDAMED08800099072023 EUDAMED08800099071989 EUDAMED08800099071972 EUDAMED
- Basic UDI-DI
- 88000990DRBY4 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
Driver 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 | 88000990DRBY4 | 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 f310ab9b-0b56-487b-9c09-bdf3fa7adff4 61 fields · synced Jul 31, 2026
- EUDAMED 80a92a4c-a854-46c4-8ed8-4db143facbcb 61 fields · synced May 17, 2026
- EUDAMED ed834a49-7ee8-4906-a958-290658a559a1 61 fields · synced May 17, 2026
- EUDAMED dbff6a6c-374c-466a-a065-9463a5e8e8cc 61 fields · synced May 19, 2026