Identity
- Trade Name
- MIFILL HYDRO SHINE PLUS EUDAMED
- Device Name
- MIFILL HYDRO SHINE PLUS EUDAMED
- Model / Reference
- BPB27-31JC EUDAMEDBPB27-31 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947980367 EUDAMED08809947980329 EUDAMED
- Basic UDI-DI
- B-08809947980367 EUDAMEDB-08809947980329 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
Mifill Hydro Shine Plus 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-08809947980367 | 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 (2)
- EUDAMED 63b06c8f-28db-438e-b867-59eafccf30dc 61 fields · synced Jul 24, 2026
- EUDAMED 1c3cb0e6-59e8-4aca-83f9-8139412f8b15 61 fields · synced May 19, 2026