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Vel. Volume
EUDAMEDClass III (EU MDR)
Ref BPLN4-60BCRef BPLN2-60JCRef BPLN-60Ref BPLN4-60JCRef BPLN-60BC
Identity
- Trade Name
- VEL. VOLUME EUDAMED
- Device Name
- VEL. VOLUME EUDAMED
- Model / Reference
- BPLN4-60BC EUDAMEDBPLN2-60JC EUDAMEDBPLN-60 EUDAMEDBPLN4-60JC EUDAMEDBPLN-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639786451 EUDAMED08809639785447 EUDAMED08809639784457 EUDAMED08809639786116 EUDAMED08809639785119 EUDAMED
- Basic UDI-DI
- B-08809639786451 EUDAMEDB-08809639785447 EUDAMEDB-08809639784457 EUDAMEDB-08809639786116 EUDAMEDB-08809639785119 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
Vel. Volume 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-08809639786451 | 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 (5)
- EUDAMED c4f025d4-ccdc-48da-a2c2-4dfbdb3eeb52 61 fields · synced Sep 17, 2026
- EUDAMED f90ed574-764b-4b6d-bbf3-eb32581c0e74 61 fields · synced May 17, 2026
- EUDAMED 434f5a1e-92bf-4af3-b7a3-facad7838bae 61 fields · synced May 17, 2026
- EUDAMED 98cdad34-65e4-4e03-9eaf-8e3409c1d011 61 fields · synced May 18, 2026
- EUDAMED b605d422-ecbb-48fe-bcbc-dd2845c92fe7 61 fields · synced May 18, 2026