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Helene All

EUDAMED

Class III (EU MDR)

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

by BioPlus Co., Ltd.

Identity

Trade Name
HELENE ALL EUDAMED
Device Name
HELENE ALL EUDAMED
Model / Reference
BPLN2-60JC EUDAMED
BPLN-60JC EUDAMED
BPLN2-60BC EUDAMED
BPLN4-60JC EUDAMED
BPLN-60BC EUDAMED

Identifiers

Primary DI / UDI-DI
08809639785461 EUDAMED
08809639784808 EUDAMED
08809639785805 EUDAMED
08809639786130 EUDAMED
08809639785126 EUDAMED
Basic UDI-DI
B-08809639785461 EUDAMED
B-08809639784808 EUDAMED
B-08809639785805 EUDAMED
B-08809639786130 EUDAMED
B-08809639785126 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

Helene All 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 0aa63032-79e5-4b6f-8084-9d91c53e0739 61 fields · synced Jul 29, 2026
  • EUDAMED 4677f124-e39c-4ec2-aa8a-66bca69ae8e9 61 fields · synced May 16, 2026
  • EUDAMED 26d7c80f-0b05-4b9b-97ee-c9c1cfbe66fd 61 fields · synced May 18, 2026
  • EUDAMED 43c6209a-0a7b-4292-a54c-51ed2838d1e6 61 fields · synced May 18, 2026
  • EUDAMED 7484bff3-8461-4e15-831c-49846bd64956 61 fields · synced May 19, 2026