Identity
- Trade Name
- Beads Max CLASSIC-H EUDAMED
- Device Name
- Beads Max CLASSIC-H EUDAMED
- Model / Reference
- BPL100-60BC EUDAMEDBPL100-60C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639786918 EUDAMED08809639786796 EUDAMED
- Basic UDI-DI
- B-08809639786918 EUDAMEDB-08809639786796 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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 CLASSIC-H 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-08809639786918 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioPlus Co., Ltd.
- EUDAMED SRN
- KR-MF-000008618
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED cf6a86f3-205a-48cd-abde-e131b36a903a 61 fields · synced Jul 16, 2026
- EUDAMED 81f8aad6-cb7c-4ca8-935a-08f889da8f22 61 fields · synced May 19, 2026