Identity
- Trade Name
- Glamour HA (Mid) EUDAMED
- Device Name
- Glamour HA (Mid) EUDAMED
- Model / Reference
- BPLN3-27JC EUDAMEDBPLN3-27BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639788080 EUDAMED08809639788417 EUDAMED
- Basic UDI-DI
- B-08809639788080 EUDAMEDB-08809639788417 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 (Mid) 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-08809639788080 | 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 70e45c58-a8ad-4b4d-971f-9c105aa90b0d 61 fields · synced Jul 30, 2026
- EUDAMED 41764688-0806-44db-b0f2-e16daf782fe1 61 fields · synced May 18, 2026