← Back to catalogue

Helene Mid

EUDAMED

Class III (EU MDR)

Ref BPLN3-27JCRef BPLN3-27BCRef BPLN-27BCRef BPLN-27JCRef BPLN-27

by BioPlus Co., Ltd.

Identity

Trade Name
HELENE MID EUDAMED
Device Name
HELENE MID EUDAMED
Model / Reference
BPLN3-27JC EUDAMED
BPLN3-27BC EUDAMED
BPLN-27BC EUDAMED
BPLN-27JC EUDAMED
BPLN-27 EUDAMED

Identifiers

Primary DI / UDI-DI
08809639788165 EUDAMED
08809639788493 EUDAMED
08809639787830 EUDAMED
08809639787540 EUDAMED
08809639787229 EUDAMED
Basic UDI-DI
B-08809639788165 EUDAMED
B-08809639788493 EUDAMED
B-08809639787830 EUDAMED
B-08809639787540 EUDAMED
B-08809639787229 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 Mid 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (5)

  • EUDAMED 69c1290c-12d2-4f23-a833-ca40e3094c9f 61 fields · synced Aug 2, 2026
  • EUDAMED c72bb0ba-f935-430e-bdde-dc8c30464420 61 fields · synced May 17, 2026
  • EUDAMED 631e89bb-7881-4c23-8edd-b633b560b5ef 61 fields · synced May 18, 2026
  • EUDAMED 6335effd-01ee-4703-9e6b-73f5b5a97214 61 fields · synced May 19, 2026
  • EUDAMED e7fa02e6-1c43-4e7a-8873-e04204f3438c 61 fields · synced May 19, 2026