Identity
- Trade Name
- Glamour HA (Shine) EUDAMED
- Device Name
- Glamour HA (Shine) EUDAMED
- Model / Reference
- BPB27-31BC EUDAMEDBPB27-31 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947980381 EUDAMED08809947980312 EUDAMED
- Basic UDI-DI
- B-08809947980381 EUDAMEDB-08809947980312 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 (Shine) 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-08809947980381 | 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 f5079c1a-b621-4f0d-aa8e-3416e4775d67 61 fields · synced Jul 31, 2026
- EUDAMED f9f9ced3-00bb-4b7e-8095-138dfc0111e2 61 fields · synced May 18, 2026