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Aqufill Medium
EUDAMEDClass III (EU MDR)
Ref BPLN3-27BCRef BPLN3-27JCRef BPLN-27BC
Identity
- Trade Name
- Aqufill Medium EUDAMED
- Device Name
- Aqufill Medium EUDAMED
- Model / Reference
- BPLN3-27BC EUDAMEDBPLN3-27JC EUDAMEDBPLN-27BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639788301 EUDAMED08809639787977 EUDAMED08809639787670 EUDAMED
- Basic UDI-DI
- B-08809639788301 EUDAMEDB-08809639787977 EUDAMEDB-08809639787670 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 Medium 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-08809639788301 | 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 d5d40027-911c-43ad-bce4-9f73b3c4859c 61 fields · synced Jul 16, 2026
- EUDAMED c85d0741-c602-4797-a2c4-c8d710e7d74e 61 fields · synced May 18, 2026
- EUDAMED 40e4648f-373a-4835-a149-d24c55b08e89 61 fields · synced May 19, 2026