Identity
- Trade Name
- aqufill Soft EUDAMED
- Device Name
- aqufill Soft EUDAMED
- Model / Reference
- BPLN-30 EUDAMEDBPLN-30BC EUDAMEDBPLN-30JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639788639 EUDAMED08809639789308 EUDAMED08809639788981 EUDAMED
- Basic UDI-DI
- B-08809639788639 EUDAMEDB-08809639789308 EUDAMEDB-08809639788981 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany 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
aqufill Soft 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-08809639788639 | 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 18f2f4ac-92b2-4a44-899b-bbfdfb47f787 61 fields · synced Jul 17, 2026
- EUDAMED bdde34c0-8195-4ff0-a7b2-d2f3237e9215 61 fields · synced May 16, 2026
- EUDAMED 9c1790c3-e38e-44a6-a395-8fe283d27a8d 61 fields · synced May 17, 2026