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Glamour HA (Soft)
EUDAMEDClass III (EU MDR)
Ref BPLN-30BCRef BPLN-30JCRef BPLN-30
Identity
- Trade Name
- Glamour HA (Soft) EUDAMED
- Device Name
- Glamour HA (Soft) EUDAMED
- Model / Reference
- BPLN-30BC EUDAMEDBPLN-30JC EUDAMEDBPLN-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639789391 EUDAMED08809639789094 EUDAMED08809639788769 EUDAMED
- Basic UDI-DI
- B-08809639789391 EUDAMEDB-08809639789094 EUDAMEDB-08809639788769 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
Glamour HA (Soft) 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-08809639789391 | 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 fb206363-b23d-4a80-a201-6ed3f7ef099c 61 fields · synced Jul 19, 2026
- EUDAMED c735219d-f2f8-4e8d-9464-f58cffa5a6c6 61 fields · synced May 19, 2026
- EUDAMED 7021500a-2fd2-4fc2-b960-3502c86435e8 61 fields · synced May 19, 2026