Identity
- Trade Name
- Blade EUDAMED
- Device Name
- Blade EUDAMED
- Model / Reference
- SDB15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800099090973 EUDAMED
- Basic UDI-DI
- 88000990BDEWN 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
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 | 88000990BDEWN | 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 (1)
- EUDAMED 19ec2b19-52b9-4d96-85e4-0fbdb5bfff89 61 fields · synced Jun 18, 2026