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Novacutan FBio DVS Volume
EUDAMEDClass III (EU MDR)
Ref BPLN2-60BCRef BPLN4-60JCRef BPLN2-60JCRef BPLN-60Ref BPLN-60JCRef BPLN4-60BCRef BPLN-60BC
Identity
- Trade Name
- Novacutan FBio DVS Volume EUDAMED
- Device Name
- Novacutan FBio DVS Volume EUDAMED
- Model / Reference
- BPLN2-60BC EUDAMEDBPLN4-60JC EUDAMEDBPLN2-60JC EUDAMEDBPLN-60 EUDAMEDBPLN-60JC EUDAMEDBPLN4-60BC EUDAMEDBPLN-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639786024 EUDAMED08809639786376 EUDAMED08809639785706 EUDAMED08809639784716 EUDAMED08809639785041 EUDAMED08809639786710 EUDAMED08809639785355 EUDAMED
- Basic UDI-DI
- B-08809639786024 EUDAMEDB-08809639786376 EUDAMEDB-08809639785706 EUDAMEDB-08809639784716 EUDAMEDB-08809639785041 EUDAMEDB-08809639786710 EUDAMEDB-08809639785355 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMEDTürkiye 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 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-08809639786024 | 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 b9d5db12-f237-4159-a1ec-c8e6d8d61f35 61 fields · synced Aug 2, 2026
- EUDAMED 5625cd25-4972-4427-aec6-83e0554de67c 61 fields · synced May 16, 2026
- EUDAMED ba78d959-8fbc-460a-8911-e84420c097d0 61 fields · synced May 17, 2026
- EUDAMED 6c7eb578-c1f7-49d9-895d-98fa7c621a66 61 fields · synced May 17, 2026
- EUDAMED a6d7b3aa-34c6-426f-9ac5-8221ce1c3d27 61 fields · synced May 17, 2026
- EUDAMED b1a50030-e3b9-4ab7-b484-21849ba0fca6 61 fields · synced May 18, 2026
- EUDAMED 03a214e9-9e03-4398-8593-191235357ed5 61 fields · synced May 18, 2026