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Mixo Volume
EUDAMEDClass III (EU MDR)
Ref BPLN4-60BCRef BPLN-60JCRef BPLN-60Ref BPLN2-60BCRef BPLN4-60JCRef BPLN2-60JC
Identity
- Trade Name
- MIXO VOLUME EUDAMED
- Device Name
- MIXO VOLUME EUDAMED
- Model / Reference
- BPLN4-60BC EUDAMEDBPLN-60JC EUDAMEDBPLN-60 EUDAMEDBPLN2-60BC EUDAMEDBPLN4-60JC EUDAMEDBPLN2-60JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639786703 EUDAMED08809639785034 EUDAMED08809639784709 EUDAMED08809639786017 EUDAMED08809639786369 EUDAMED08809639785690 EUDAMED
- Basic UDI-DI
- B-08809639786703 EUDAMEDB-08809639785034 EUDAMEDB-08809639784709 EUDAMEDB-08809639786017 EUDAMEDB-08809639786369 EUDAMEDB-08809639785690 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany 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
Mixo 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-08809639786703 | 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 (6)
- EUDAMED 41e9bd3c-84e2-435e-81ad-e6e144ee0e56 61 fields · synced Jul 25, 2026
- EUDAMED 41930945-82ff-464b-bb02-5e33f3d0e1ad 61 fields · synced May 17, 2026
- EUDAMED 97fe289c-6dc8-4632-aedc-a7c9c7ef52d6 61 fields · synced May 18, 2026
- EUDAMED 43dca34c-8007-427b-a3bb-33e47befc8d4 61 fields · synced May 18, 2026
- EUDAMED f71040f7-db7c-41f8-8461-829edf6848c8 61 fields · synced May 18, 2026
- EUDAMED 95294d99-3ab0-4b2c-9684-bc36b47a824c 61 fields · synced May 19, 2026