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Blade for CMF Surgery
EUDAMEDClass I (EU MDR)
Ref SEB-15CRef SDB-20C-C-SQRef SDB-23C-90Ref SDB-20C-80Ref SDB-15C-82Ref SDB-1265X1Ref SEB-20CRef UEB-20CRef SDB-20C-90Ref LEB-20CRef SDB-15C-60Ref SDB-23C-60
Identity
- Device Name
- Blade for CMF Surgery EUDAMED
- Model / Reference
- SEB-15C EUDAMEDSDB-20C-C-SQ EUDAMEDSDB-23C-90 EUDAMEDSDB-20C-80 EUDAMEDSDB-15C-82 EUDAMEDSDB-1265X1 EUDAMEDSEB-20C EUDAMEDUEB-20C EUDAMEDSDB-20C-90 EUDAMEDLEB-20C EUDAMEDSDB-15C-60 EUDAMEDSDB-23C-60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800099071651 EUDAMED08800099071521 EUDAMED08800099071583 EUDAMED08800099071606 EUDAMED08800099071613 EUDAMED08800099071545 EUDAMED08800099071644 EUDAMED08800099071569 EUDAMED08800099071507 EUDAMED08800099071477 EUDAMED08800099071620 EUDAMED08800099071491 EUDAMED
- Basic UDI-DI
- 88000990CSBY2 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
Blade for CMF Surgery 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 | 88000990CSBY2 | 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 (12)
- EUDAMED b3fb9d78-9403-4b3c-8483-27b62bf436d0 61 fields · synced Aug 2, 2026
- EUDAMED d3a80ae2-5d58-4e62-aa85-784216d64112 61 fields · synced May 16, 2026
- EUDAMED 2d579fbc-7b68-427b-b61d-653f4a597cb6 61 fields · synced May 16, 2026
- EUDAMED d93dddb9-3536-4bca-8fd9-0aa8266c054f 61 fields · synced May 16, 2026
- EUDAMED 5be86094-69ac-4a7b-8f35-39a9d94591ae 61 fields · synced May 17, 2026
- EUDAMED fc1dfd9d-1b1c-406c-90aa-6589b40098c3 61 fields · synced May 17, 2026
- EUDAMED fdb22427-dffa-4d8b-99e0-ab5fe17607a6 61 fields · synced May 17, 2026
- EUDAMED 617907d8-e50c-435a-b71b-bdec096d3dc0 61 fields · synced May 17, 2026
- EUDAMED 6d298761-d27e-4b7a-b95b-850b634de2d8 61 fields · synced May 18, 2026
- EUDAMED 433462b2-c676-4ff6-aeab-3183e0991b4e 61 fields · synced May 18, 2026
- EUDAMED 231a3fee-f85b-4bb7-8a01-ec84fae79e68 61 fields · synced May 18, 2026
- EUDAMED 294a4f80-f72e-48ff-be32-1ab78e692bd6 61 fields · synced May 19, 2026