← Back to catalogue
Elaxfill Volume
EUDAMEDClass III (EU MDR)
Ref BPLN2-60BCRef BPLN-60Ref BPLN-60BCRef BPLN2-60JC
Identity
- Trade Name
- ELAXFILL VOLUME EUDAMED
- Device Name
- ELAXFILL VOLUME EUDAMED
- Model / Reference
- BPLN2-60BC EUDAMEDBPLN-60 EUDAMEDBPLN-60BC EUDAMEDBPLN2-60JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639785966 EUDAMED08809639784655 EUDAMED08809639785294 EUDAMED08809639785645 EUDAMED
- Basic UDI-DI
- B-08809639785966 EUDAMEDB-08809639784655 EUDAMEDB-08809639785294 EUDAMEDB-08809639785645 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
Elaxfill Volume 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-08809639785966 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioPlus Co., Ltd.
- EUDAMED SRN
- KR-MF-000008618
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (4)
- EUDAMED 4ae20ccc-4300-440a-930a-9ef263c0b8d4 61 fields · synced Jul 13, 2026
- EUDAMED 91e96ec3-1a90-42e0-920f-dbe78379ccd6 61 fields · synced May 18, 2026
- EUDAMED bb5d8b00-518e-418c-bc3b-3d96f96057a2 61 fields · synced May 18, 2026
- EUDAMED 7790c9a9-a065-40b7-a71b-0b97fdc98346 61 fields · synced May 18, 2026