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Bellus Volume
EUDAMEDClass III (EU MDR)
Ref BPLN-60JCRef BPLN2-60BCRef BPLN4-60JCRef BPLN2-60JCRef BPLN-60BCRef BPLN4-60BCRef BPLN-60
Identity
- Trade Name
- BELLUS VOLUME EUDAMED
- Device Name
- BELLUS VOLUME EUDAMED
- Model / Reference
- BPLN-60JC EUDAMEDBPLN2-60BC EUDAMEDBPLN4-60JC EUDAMEDBPLN2-60JC EUDAMEDBPLN-60BC EUDAMEDBPLN4-60BC EUDAMEDBPLN-60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947980749 EUDAMED08809947981289 EUDAMED08809947981470 EUDAMED08809947981128 EUDAMED08809947980930 EUDAMED08809947981661 EUDAMED08809947980558 EUDAMED
- Basic UDI-DI
- B-08809947980749 EUDAMEDB-08809947981289 EUDAMEDB-08809947981470 EUDAMEDB-08809947981128 EUDAMEDB-08809947980930 EUDAMEDB-08809947981661 EUDAMEDB-08809947980558 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
Bellus 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-08809947980749 | 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 (7)
- EUDAMED dde18e7b-9eb3-4be4-8e73-567f3b7dde85 61 fields · synced Sep 18, 2026
- EUDAMED f4dc3ba1-c79e-4dee-a121-8a237c44c7e4 61 fields · synced May 16, 2026
- EUDAMED 7daa4859-7273-45d8-bb29-92873afc2076 61 fields · synced May 17, 2026
- EUDAMED 0c8d3616-beab-48fe-9ea7-49a9d322202f 61 fields · synced May 17, 2026
- EUDAMED 49c58fa7-8214-43ca-865a-1802193cd7c9 61 fields · synced May 18, 2026
- EUDAMED 7a52dc29-4484-44c9-8667-dc8e1b38b6c4 61 fields · synced May 19, 2026
- EUDAMED cef79f17-4344-4f95-8c71-312573ec2227 61 fields · synced May 19, 2026