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Elhya Ultra Deep

EUDAMED

Class III (EU MDR)

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

by BioPlus Co., Ltd.

Identity

Trade Name
ELHYA ULTRA DEEP EUDAMED
Device Name
ELHYA ULTRA DEEP EUDAMED
Model / Reference
BPLN4-60BC EUDAMED
BPLN-60 EUDAMED
BPLN-60BC EUDAMED
BPLN4-60JC EUDAMED
BPLN-60JC EUDAMED

Identifiers

Primary DI / UDI-DI
08809947981654 EUDAMED
08809947980541 EUDAMED
08809947980923 EUDAMED
08809947981463 EUDAMED
08809947980732 EUDAMED
Basic UDI-DI
B-08809947981654 EUDAMED
B-08809947980541 EUDAMED
B-08809947980923 EUDAMED
B-08809947981463 EUDAMED
B-08809947980732 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

Elhya Ultra Deep 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 522345f8-9767-484e-8919-7a75532f9970 61 fields · synced Jul 17, 2026
  • EUDAMED 2807efa1-dd1d-41f0-b159-840a53f0445c 61 fields · synced May 17, 2026
  • EUDAMED 490388d9-c4db-4dc0-a167-ec9f4a488aeb 61 fields · synced May 17, 2026
  • EUDAMED fe700b51-065b-4198-8d91-309a3051c6c1 61 fields · synced May 17, 2026
  • EUDAMED 78a3bae1-1bb9-4445-8840-439244338320 61 fields · synced May 18, 2026