Identity
- Trade Name
- Aqufill HYDRO EUDAMED
- Device Name
- Aqufill HYDRO EUDAMED
- Model / Reference
- BPBN-31 EUDAMEDBPBN-31BC EUDAMEDBPBN-31JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947980008 EUDAMED08809947980206 EUDAMED08809947980107 EUDAMED
- Basic UDI-DI
- B-08809947980008 EUDAMEDB-08809947980206 EUDAMEDB-08809947980107 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMEDTürkiye 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 HYDRO 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-08809947980008 | 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 a9f2ae3a-a89c-4d64-8030-65d0caa8e1c4 61 fields · synced Jul 30, 2026
- EUDAMED 7d38cbc1-1b64-48de-b944-3817424b6d03 61 fields · synced May 18, 2026
- EUDAMED 2741014b-2ee9-40f5-98d9-c1ac74f0a166 61 fields · synced May 18, 2026