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Aqufill Hard
EUDAMEDClass III (EU MDR)
Ref BPLN4-60BCRef BPLN-60BCRef BPLN2-60BCModel BPLN2-60BCRef BPLN4-60JC
Identity
- Trade Name
- Aqufill Hard EUDAMED
- Device Name
- Aqufill Hard EUDAMED
- Model / Reference
- BPLN4-60BC EUDAMEDBPLN-60BC EUDAMEDBPLN2-60BC EUDAMEDBPLN4-60JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639786420 EUDAMED08809639785089 EUDAMED08809639785751 EUDAMED08809639786086 EUDAMED
- Basic UDI-DI
- B-08809639786420 EUDAMEDB-08809639785089 EUDAMEDB-08809639785751 EUDAMEDB-08809639786086 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 Hard 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-08809639786420 | 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 92400640-216b-473b-afe4-29fe12591ba2 61 fields · synced Sep 17, 2026
- EUDAMED 973a5ea8-a27e-4a3c-864f-4394d9d69c5e 61 fields · synced May 17, 2026
- EUDAMED 67ad227c-c414-4c0b-9351-1f6a9850a4eb 61 fields · synced May 18, 2026
- EUDAMED 59a29964-f2a5-4fdc-b15f-3f8cec1bcbf2 61 fields · synced May 18, 2026