Identity
- Trade Name
- MDFILL Sub-Q EUDAMED
- Device Name
- MDFILL Sub-Q EUDAMED
- Model / Reference
- BPLN4-60BC EUDAMEDBPLN-60JC EUDAMEDBPLN-60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639786697 EUDAMED08809639785027 EUDAMED08809639784693 EUDAMED
- Basic UDI-DI
- B-08809639786697 EUDAMEDB-08809639785027 EUDAMEDB-08809639784693 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
MDFILL Sub-Q 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-08809639786697 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioPlus Co., Ltd.
- EUDAMED SRN
- KR-MF-000008618
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (3)
- EUDAMED 8254dfe1-66b4-496f-b85c-05e7b4a1ebd4 61 fields · synced Jul 23, 2026
- EUDAMED 701dc45e-0616-48f1-bd7f-c135ef0b9569 61 fields · synced May 17, 2026
- EUDAMED be343687-ea1c-48f3-b661-bb4ff0735455 61 fields · synced May 18, 2026