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Novacutan FBio DVS Medium
EUDAMEDClass III (EU MDR)
Ref BPLN-27Ref BPLN-27JCRef BPLN3-27BC
Identity
- Trade Name
- Novacutan FBio DVS Medium EUDAMED
- Device Name
- Novacutan FBio DVS Medium EUDAMED
- Model / Reference
- BPLN-27 EUDAMEDBPLN-27JC EUDAMEDBPLN3-27BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639787328 EUDAMED08809639787649 EUDAMED08809639788592 EUDAMED
- Basic UDI-DI
- B-08809639787328 EUDAMEDB-08809639787649 EUDAMEDB-08809639788592 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
Novacutan FBio DVS Medium 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-08809639787328 | 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 eaaa40e1-e6e5-4eab-8856-edf4ac4e1f08 61 fields · synced Sep 18, 2026
- EUDAMED c42da7ef-57b6-42f9-93d8-184654978b86 61 fields · synced May 18, 2026
- EUDAMED 54ff2c27-8d0a-44eb-a986-5bf52b1c0d40 61 fields · synced May 18, 2026