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Mifill Volume

EUDAMED

Class III (EU MDR)

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

by BioPlus Co., Ltd.

Identity

Trade Name
MIFILL VOLUME EUDAMED
Device Name
MIFILL VOLUME EUDAMED
Model / Reference
BPLN-60BC EUDAMED
BPLN2-60JC EUDAMED
BPLN2-60BC EUDAMED
BPLN4-60BC EUDAMED
BPLN4-60JC EUDAMED

Identifiers

Primary DI / UDI-DI
08809639782095 EUDAMED
08809639785430 EUDAMED
08809639785775 EUDAMED
08809639786444 EUDAMED
08809639786109 EUDAMED
Basic UDI-DI
B-08809639782095 EUDAMED
B-08809639785430 EUDAMED
B-08809639785775 EUDAMED
B-08809639786444 EUDAMED
B-08809639786109 EUDAMED
EMDN Code
P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED

Classification

Device Class
Class III EUDAMED
Market of Registration
Germany EUDAMED
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

Mifill Volume 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 dc75adf8-4b80-4f88-9b0b-bd11de6993a8 61 fields · synced Jul 26, 2026
  • EUDAMED cea29dee-8730-4323-aecc-954db38fdf53 61 fields · synced May 18, 2026
  • EUDAMED ca687a1b-bf9e-42c6-a9c3-937e6e470dff 61 fields · synced May 18, 2026
  • EUDAMED 43768061-0ddd-45f4-8159-cbbd6822f291 61 fields · synced May 19, 2026
  • EUDAMED a294c1a5-1443-42af-b7c6-0c31c99980df 61 fields · synced May 19, 2026