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Ammi AQUA
EUDAMEDClass III (EU MDR)
Ref BPLN-27BCRef BPLN3-27BCModel BPLN3-27BCRef BPLN-27JC
Identity
- Trade Name
- Ammi AQUA EUDAMED
- Device Name
- Ammi AQUA EUDAMED
- Model / Reference
- BPLN-27BC EUDAMEDBPLN3-27BC EUDAMEDBPLN-27JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639781418 EUDAMED08809639788295 EUDAMED08809639787359 EUDAMED
- Basic UDI-DI
- B-08809639781418 EUDAMEDB-08809639788295 EUDAMEDB-08809639787359 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
Ammi AQUA 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-08809639781418 | 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 90c70595-3e91-4929-b667-63747b5cd1a6 61 fields · synced Jul 25, 2026
- EUDAMED 8406a3ae-8f63-4526-bc5a-dc898441adfd 61 fields · synced May 18, 2026
- EUDAMED 96b20e2e-8e61-4744-a735-eec3ae3e265a 61 fields · synced May 18, 2026