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VOLLOV Volume
EUDAMEDClass III (EU MDR)
Ref BPLN4-60BCRef BPLN-60Ref BPLN-60BCRef BPLN4-60JC
Identity
- Trade Name
- VOLLOV Volume EUDAMED
- Device Name
- VOLLOV Volume EUDAMED
- Model / Reference
- BPLN4-60BC EUDAMEDBPLN-60 EUDAMEDBPLN-60BC EUDAMEDBPLN4-60JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947981586 EUDAMED08809947980473 EUDAMED08809947980855 EUDAMED08809947981395 EUDAMED
- Basic UDI-DI
- B-08809947981586 EUDAMEDB-08809947980473 EUDAMEDB-08809947980855 EUDAMEDB-08809947981395 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
VOLLOV 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-08809947981586 | 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 a3455fad-6f7f-43ad-89b8-3ac8a27b8685 61 fields · synced Jul 25, 2026
- EUDAMED 615b7bd3-7896-4379-8752-b68b1cc81b00 61 fields · synced May 18, 2026
- EUDAMED 0661543e-6fce-4694-9c38-3bf366909e8f 61 fields · synced May 18, 2026
- EUDAMED 6a9f8075-79ff-415a-9c9d-8d02d68b2b93 61 fields · synced May 18, 2026