Identity
- Trade Name
- Fineha Volume 10 EUDAMED
- Device Name
- Fineha Volume 10 EUDAMED
- Model / Reference
- BPL100-27BC EUDAMEDBPL100-27C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947984860 EUDAMED08809947984853 EUDAMED
- Basic UDI-DI
- B-08809947984860 EUDAMEDB-08809947984853 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
Fineha Volume 10 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-08809947984860 | 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 (2)
- EUDAMED 47f965ac-d538-419a-8573-7fc660266f4f 61 fields · synced Jul 27, 2026
- EUDAMED 270ccab9-5ce2-4001-8fa8-fae1bd249165 61 fields · synced May 18, 2026