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Ammi DIAMOND
EUDAMEDClass III (EU MDR)
Ref BPLN2-60JCRef BPLN4-60JCRef BPLN-60BCModel BPLN-60BC
Identity
- Trade Name
- Ammi DIAMOND EUDAMED
- Device Name
- Ammi DIAMOND EUDAMED
- Model / Reference
- BPLN2-60JC EUDAMEDBPLN4-60JC EUDAMEDBPLN-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639785409 EUDAMED08809639786079 EUDAMED08809639785072 EUDAMED
- Basic UDI-DI
- B-08809639785409 EUDAMEDB-08809639786079 EUDAMEDB-08809639785072 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
Ammi DIAMOND 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-08809639785409 | 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 2c11319a-8e7d-4fba-9882-40e3d9da79fb 61 fields · synced Jul 23, 2026
- EUDAMED f61f778a-8d0b-4939-a7b2-93fe63c7118f 61 fields · synced May 18, 2026
- EUDAMED 6b502b29-8e66-4376-8fb1-37be0b921139 61 fields · synced May 19, 2026