Identity
- Trade Name
- FILLUS FINE EUDAMED
- Device Name
- FILLUS FINE EUDAMED
- Model / Reference
- BPLN-30JC EUDAMEDBPLN-30BC EUDAMEDBPLN-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639789087 EUDAMED08809639789384 EUDAMED08809639788752 EUDAMED
- Basic UDI-DI
- B-08809639789087 EUDAMEDB-08809639789384 EUDAMEDB-08809639788752 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
Fillus Fine 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-08809639789087 | 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 a0289a1f-5a3e-49c5-915a-c63bf05f2c5a 61 fields · synced Jul 31, 2026
- EUDAMED 8778c217-68a3-4337-99f7-a8907bc5a9cd 61 fields · synced May 18, 2026
- EUDAMED 1e7f792c-c75e-4ab5-88eb-5abce8df6d8e 61 fields · synced May 18, 2026