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Ammi CRYSTAL
EUDAMEDClass III (EU MDR)
Ref BPLN-60BCModel BPLN-60BCRef BPLN4-60JCRef BPLN2-60JCRef BPLN-60JC
Identity
- Trade Name
- Ammi CRYSTAL EUDAMED
- Device Name
- Ammi CRYSTAL EUDAMED
- Model / Reference
- BPLN-60BC EUDAMEDBPLN4-60JC EUDAMEDBPLN2-60JC EUDAMEDBPLN-60JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639781401 EUDAMED08809639786062 EUDAMED08809639785393 EUDAMED08809639784747 EUDAMED
- Basic UDI-DI
- B-08809639781401 EUDAMEDB-08809639786062 EUDAMEDB-08809639785393 EUDAMEDB-08809639784747 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 CRYSTAL 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-08809639781401 | 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 073bc3de-d4e8-4b5a-8c21-8e7ce29460f7 61 fields · synced Sep 18, 2026
- EUDAMED 1b29e67f-54cd-4d73-893b-d2bba3a4ba6d 61 fields · synced May 18, 2026
- EUDAMED cda805a2-7583-4d4b-96fe-8902c1c23d6a 61 fields · synced May 18, 2026
- EUDAMED 174639b6-e8f1-49d8-b01f-5aaa7a3097e8 61 fields · synced May 19, 2026