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BiViDerma V

EUDAMED

Class III (EU MDR)

Ref BPLN2-60BCRef BPLN-60BCRef BPLN-60Ref BPLN2-60JCRef BPLN4-60BCRef BPLN4-60JC

by BioPlus Co., Ltd.

Identity

Trade Name
BiViDerma V EUDAMED
Device Name
BiViDerma V EUDAMED
Model / Reference
BPLN2-60BC EUDAMED
BPLN-60BC EUDAMED
BPLN-60 EUDAMED
BPLN2-60JC EUDAMED
BPLN4-60BC EUDAMED
BPLN4-60JC EUDAMED

Identifiers

Primary DI / UDI-DI
08809639785843 EUDAMED
08809639782811 EUDAMED
08809639784518 EUDAMED
08809639785508 EUDAMED
08809639786512 EUDAMED
08809639786178 EUDAMED
Basic UDI-DI
B-08809639785843 EUDAMED
B-08809639782811 EUDAMED
B-08809639784518 EUDAMED
B-08809639785508 EUDAMED
B-08809639786512 EUDAMED
B-08809639786178 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

BiViDerma V 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

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Manufacturer

Manufacturer
BioPlus Co., Ltd.
EUDAMED SRN
KR-MF-000008618
Authorised Representative
KTR Europe GmbH DE-AR-000005685

Sources (6)

  • EUDAMED ff44477f-76af-4422-a3c3-19180c82980d 61 fields · synced Aug 1, 2026
  • EUDAMED 19fa808c-8871-4540-a1e9-58bd2218e5ec 61 fields · synced May 17, 2026
  • EUDAMED 215a973e-cb80-47e6-9e29-03df0c889fd4 61 fields · synced May 18, 2026
  • EUDAMED 6811f24b-cb4d-45bf-a2d0-7fb889e6e9df 61 fields · synced May 18, 2026
  • EUDAMED b2d09060-35f6-4924-a0f4-80a63adb5d19 61 fields · synced May 18, 2026
  • EUDAMED 65d9c50b-6f8b-44a4-a5f8-9064d888dae2 61 fields · synced May 18, 2026