Identity
- Trade Name
- Vanguard Super Implant EUDAMED
- Device Name
- Vanguard Super Implant EUDAMED
- Model / Reference
- BPLN-100 EUDAMEDBPLN-100BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947984990 EUDAMED08809947985003 EUDAMED
- Basic UDI-DI
- B-08809947984990 EUDAMEDB-08809947985003 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
Vanguard Super Implant 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-08809947984990 | 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 (2)
- EUDAMED 09fe0a8a-d108-4ba9-9166-3c0ce36e8241 61 fields · synced Jul 30, 2026
- EUDAMED 3501f9d3-6197-451d-9cfc-d6d38e881b33 61 fields · synced May 18, 2026