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DeneB Median
EUDAMEDClass III (EU MDR)
Ref BPL30-27BCRef BPL30-27JCRef BPL30-27
Identity
- Trade Name
- DeneB Median EUDAMED
- Device Name
- DeneB Median EUDAMED
- Model / Reference
- BPL30-27BC EUDAMEDBPL30-27JC EUDAMEDBPL30-27 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639783214 EUDAMED08809639789704 EUDAMED08809639783207 EUDAMED
- Basic UDI-DI
- B-08809639783214 EUDAMEDB-08809639789704 EUDAMEDB-08809639783207 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
DeneB Median by BioPlus Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809639783214 | Class III | Active |
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Manufacturer
- Manufacturer
- BioPlus Co., Ltd.
- EUDAMED SRN
- KR-MF-000008618
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (3)
- EUDAMED 8383e5ed-699c-4afb-8a6e-953a4a8e6333 61 fields · synced Jul 28, 2026
- EUDAMED 134b05be-5428-418a-a263-7e5cd6ef24b3 61 fields · synced May 18, 2026
- EUDAMED 39a22edd-dbbb-4b11-afad-614bf7d5f13d 61 fields · synced May 18, 2026