Identity
- Trade Name
- HELENE SMOOTH EUDAMED
- Device Name
- HELENE SMOOTH EUDAMED
- Model / Reference
- BPLN-30BC EUDAMEDBPLN-30 EUDAMEDBPLN-30JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639789339 EUDAMED08809639788684 EUDAMED08809639781289 EUDAMED
- Basic UDI-DI
- B-08809639789339 EUDAMEDB-08809639788684 EUDAMEDB-08809639781289 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 Smooth 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809639789339 | Class III | Active |
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Manufacturer
- Manufacturer
- BioPlus Co., Ltd.
- EUDAMED SRN
- KR-MF-000008618
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (3)
- EUDAMED 0e3ec670-a54e-4360-858f-90b64c7e948a 61 fields · synced Jul 29, 2026
- EUDAMED 1b1157c6-4ff3-4986-822e-15d8223c21cb 61 fields · synced May 18, 2026
- EUDAMED a8425956-5590-48bd-84a5-5bda2e866fdc 61 fields · synced May 18, 2026