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Dermafill MD DermaShine
EUDAMEDClass III (EU MDR)
Ref BPBN-31JCRef BPBN-31BCRef BPBN-31
Identity
- Trade Name
- Dermafill MD DermaShine EUDAMED
- Device Name
- Dermafill MD DermaShine EUDAMED
- Model / Reference
- BPBN-31JC EUDAMEDBPBN-31BC EUDAMEDBPBN-31 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947980145 EUDAMED08809947980244 EUDAMED08809947980039 EUDAMED
- Basic UDI-DI
- B-08809947980145 EUDAMEDB-08809947980244 EUDAMEDB-08809947980039 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
Dermafill MD DermaShine 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-08809947980145 | 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 da65fd64-60c6-4a2a-bb5b-f62cdc03dfd0 61 fields · synced Jul 23, 2026
- EUDAMED 64f7efaf-18bd-425c-b71b-adc262205f9d 61 fields · synced May 18, 2026
- EUDAMED 75439a6f-65c6-4845-9ec2-064c915dca2f 61 fields · synced May 18, 2026