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Filerah HARD

EUDAMED

Class III (EU MDR)

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

by BioPlus Co., Ltd.

Identity

Trade Name
Filerah HARD EUDAMED
Device Name
Filerah HARD EUDAMED
Model / Reference
BPLN-60JC EUDAMED
BPLN-60 EUDAMED
BPLN2-60JC EUDAMED
BPLN2-60BC EUDAMED
BPLN4-60BC EUDAMED

Identifiers

Primary DI / UDI-DI
08809639784907 EUDAMED
08809639784570 EUDAMED
08809639785560 EUDAMED
08809639785898 EUDAMED
08809639786574 EUDAMED
Basic UDI-DI
B-08809639784907 EUDAMED
B-08809639784570 EUDAMED
B-08809639785560 EUDAMED
B-08809639785898 EUDAMED
B-08809639786574 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

Filerah HARD 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 (5)

  • EUDAMED b191b789-bcc0-483a-b913-74312d94d1de 61 fields · synced Sep 18, 2026
  • EUDAMED 25b3b9df-54d5-4535-8095-9eb8128e1a84 61 fields · synced May 16, 2026
  • EUDAMED 2f66721d-940e-4cfe-afdc-79058a308585 61 fields · synced May 17, 2026
  • EUDAMED 0753700f-ae57-4dee-9fe7-67923d187679 61 fields · synced May 17, 2026
  • EUDAMED a22cf3a2-888e-46fe-ae36-67cc68c46107 61 fields · synced May 18, 2026