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BoLCA ESTHIA SOLID
EUDAMEDClass III (EU MDR)
Ref BPLN4-60JCRef BPLN2-60BCRef BPLN-60Ref BPLN4-60BC
Identity
- Trade Name
- BoLCA ESTHIA SOLID EUDAMED
- Device Name
- BoLCA ESTHIA SOLID EUDAMED
- Model / Reference
- BPLN4-60JC EUDAMEDBPLN2-60BC EUDAMEDBPLN-60 EUDAMEDBPLN4-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639786338 EUDAMED08809639785980 EUDAMED08809639784679 EUDAMED08809639786673 EUDAMED
- Basic UDI-DI
- B-08809639786338 EUDAMEDB-08809639785980 EUDAMEDB-08809639784679 EUDAMEDB-08809639786673 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
BoLCA ESTHIA SOLID 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-08809639786338 | 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 (4)
- EUDAMED 01116cb3-98c3-4998-b99e-6169bb14a43d 61 fields · synced Aug 3, 2026
- EUDAMED b56a2cb8-f2a0-4cc1-a7fb-1e8b0275c515 61 fields · synced May 17, 2026
- EUDAMED 34ef5f18-e6f8-467b-8e15-545eebd7cf8d 61 fields · synced May 18, 2026
- EUDAMED efb3f374-60e2-40c8-9c12-99bb9cb2f23d 61 fields · synced May 18, 2026