Identity
- Trade Name
- LINEFeel Contour Ultra EUDAMED
- Device Name
- LINEFeel Contour Ultra EUDAMED
- Model / Reference
- BPLN2-100BC EUDAMEDBPLN2-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639784396 EUDAMED08809639784372 EUDAMED
- Basic UDI-DI
- B-08809639784396 EUDAMEDB-08809639784372 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
LINEFeel Contour Ultra 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-08809639784396 | 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 (2)
- EUDAMED bee08a14-7c24-4666-9e50-381c28661eaa 61 fields · synced Jul 19, 2026
- EUDAMED e8e74b14-195e-4adc-872e-c8a533ed69e6 61 fields · synced May 17, 2026