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Volume In Misfill+
EUDAMEDClass III (EU MDR)
Ref BPLN2-60JCRef BPLN4-60BCRef BPLN4-60JC
Identity
- Trade Name
- VOLUME IN MISFILL+ EUDAMED
- Device Name
- VOLUME IN MISFILL+ EUDAMED
- Model / Reference
- BPLN2-60JC EUDAMEDBPLN4-60BC EUDAMEDBPLN4-60JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639785454 EUDAMED08809639786468 EUDAMED08809639786123 EUDAMED
- Basic UDI-DI
- B-08809639785454 EUDAMEDB-08809639786468 EUDAMEDB-08809639786123 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
Volume In Misfill+ 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-08809639785454 | 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 (3)
- EUDAMED 38948d19-ab78-4d72-a2d0-06e901715e2c 61 fields · synced Jul 8, 2026
- EUDAMED 4f2f804b-5aa1-472c-a1d8-5df7519806da 61 fields · synced May 18, 2026
- EUDAMED a94d0fb4-2a1d-475e-93cd-9e6bc97985f0 61 fields · synced May 19, 2026