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DeneB Classic-H
EUDAMEDClass III (EU MDR)
Ref BPL100-100CRef BPL100-60CRef BPL100-100BCRef BPL100-60BC
Identity
- Trade Name
- DeneB Classic-H EUDAMED
- Device Name
- DeneB Classic-H EUDAMED
- Model / Reference
- BPL100-100C EUDAMEDBPL100-60C EUDAMEDBPL100-100BC EUDAMEDBPL100-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639783016 EUDAMED08809639783122 EUDAMED08809639783023 EUDAMED08809639783139 EUDAMED
- Basic UDI-DI
- B-08809639783016 EUDAMEDB-08809639783122 EUDAMEDB-08809639783023 EUDAMEDB-08809639783139 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany 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 Classic-H 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-08809639783016 | 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 (4)
- EUDAMED b1e15904-5b44-4508-9bbf-bc9c9d0b9800 61 fields · synced Jul 26, 2026
- EUDAMED 2d1a29e1-5340-4771-9146-f794cae05b87 61 fields · synced May 17, 2026
- EUDAMED f38948a3-3464-4bbf-a5c0-4cdf92b932c4 61 fields · synced May 18, 2026
- EUDAMED bafa262c-7ed9-4e68-933d-7224b2fbd400 61 fields · synced May 18, 2026