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Beads Max High
EUDAMEDClass III (EU MDR)
Ref BPLN-60Ref BPLN-60JCRef BPLN-60BCRef BPLN4-60JCRef BPLN4-60BCRef BPLN2-60BCRef BPLN2-60JC
Identity
- Trade Name
- Beads Max High EUDAMED
- Device Name
- Beads Max High EUDAMED
- Model / Reference
- BPLN-60 EUDAMEDBPLN-60JC EUDAMEDBPLN-60BC EUDAMEDBPLN4-60JC EUDAMEDBPLN4-60BC EUDAMEDBPLN2-60BC EUDAMEDBPLN2-60JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639784501 EUDAMED08809639784839 EUDAMED08809639785157 EUDAMED08809639786161 EUDAMED08809639786505 EUDAMED08809639785836 EUDAMED08809639785492 EUDAMED
- Basic UDI-DI
- B-08809639784501 EUDAMEDB-08809639784839 EUDAMEDB-08809639785157 EUDAMEDB-08809639786161 EUDAMEDB-08809639786505 EUDAMEDB-08809639785836 EUDAMEDB-08809639785492 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye 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
Beads Max High 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-08809639784501 | 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 (7)
- EUDAMED ee334b70-ba1b-4f06-b991-96365bda190a 61 fields · synced Jul 18, 2026
- EUDAMED e3e309aa-ef9a-4a3d-a2f9-b8ed2e3fcc0c 61 fields · synced May 16, 2026
- EUDAMED 4c95ffa4-63ef-489e-b01c-b2ce5ca6c9a1 61 fields · synced May 17, 2026
- EUDAMED d33fe9ee-105b-4551-bccc-7ff35f01e41c 61 fields · synced May 18, 2026
- EUDAMED abcb11fe-f460-4e81-97f1-6cb89d1efbd2 61 fields · synced May 18, 2026
- EUDAMED 1004a75f-e159-4f41-859a-4cd841e0af2e 61 fields · synced May 18, 2026
- EUDAMED a8c78fc6-9ed7-4b37-bb37-c5c9752224ce 61 fields · synced May 18, 2026