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BoLCA ESTHIA VOLUPTY FILL FIRM
EUDAMEDClass III (EU MDR)
Ref BPL100-60CRef BPL100-60BC
Identity
- Trade Name
- BoLCA ESTHIA VOLUPTY FILL FIRM EUDAMED
- Device Name
- BoLCA ESTHIA VOLUPTY FILL FIRM EUDAMED
- Model / Reference
- BPL100-60C EUDAMEDBPL100-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639786840 EUDAMED08809639786963 EUDAMED
- Basic UDI-DI
- B-08809639786840 EUDAMEDB-08809639786963 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 VOLUPTY FILL FIRM 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-08809639786840 | 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 29e72f94-d254-4757-9868-8edd04d675ea 61 fields · synced Jul 28, 2026
- EUDAMED 8e7dbf31-3142-42d7-99ad-1e093450939b 61 fields · synced May 18, 2026