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Selkiee Sub-Q

EUDAMED

Class III (EU MDR)

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

by BioPlus Co., Ltd.

Identity

Trade Name
SELKIEE SUB-Q EUDAMED
Device Name
SELKIEE SUB-Q EUDAMED
Model / Reference
BPLN-60 EUDAMED
BPLN-60JC EUDAMED
BPLN4-60JC EUDAMED
BPLN2-60JC EUDAMED
BPLN2-60BC EUDAMED

Identifiers

Primary DI / UDI-DI
08809947983832 EUDAMED
08809947983849 EUDAMED
08809947983887 EUDAMED
08809947983863 EUDAMED
08809947983870 EUDAMED
Basic UDI-DI
B-08809947983832 EUDAMED
B-08809947983849 EUDAMED
B-08809947983887 EUDAMED
B-08809947983863 EUDAMED
B-08809947983870 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

Selkiee 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

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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 5fa7d065-f566-4acf-a547-f113488bc3fd 61 fields · synced Jul 30, 2026
  • EUDAMED fa932b0e-234c-4944-8626-545b7095d1df 61 fields · synced May 16, 2026
  • EUDAMED bcf1d933-1aa7-4b40-bfd6-c6c43266070c 61 fields · synced May 17, 2026
  • EUDAMED ae06cb6c-6bbf-47d7-b837-97c716d15898 61 fields · synced May 18, 2026
  • EUDAMED ed3e5e9d-7e4c-4d50-af60-867934443908 61 fields · synced May 19, 2026