← Back to catalogue
Glamour HA (Hard)
EUDAMEDClass III (EU MDR)
Ref BPLN4-60BCRef BPLN-60Ref BPLN2-60BCRef BPLN2-60JC
Identity
- Trade Name
- Glamour HA (Hard) EUDAMED
- Device Name
- Glamour HA (Hard) EUDAMED
- Model / Reference
- BPLN4-60BC EUDAMEDBPLN-60 EUDAMEDBPLN2-60BC EUDAMEDBPLN2-60JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639786550 EUDAMED08809639784556 EUDAMED08809639785874 EUDAMED08809639785546 EUDAMED
- Basic UDI-DI
- B-08809639786550 EUDAMEDB-08809639784556 EUDAMEDB-08809639785874 EUDAMEDB-08809639785546 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 (Hard) 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-08809639786550 | 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 (4)
- EUDAMED 621ca0a3-fe06-4a03-abbc-571dba1f49c6 61 fields · synced Sep 18, 2026
- EUDAMED ed030db5-9e7c-49b8-89f1-48fa4ad0b601 61 fields · synced May 16, 2026
- EUDAMED 17aadc1d-401e-4bd1-ad3b-56665bdc65f3 61 fields · synced May 17, 2026
- EUDAMED 68f2f7fb-0a34-48e5-a72e-932ac7eb5810 61 fields · synced May 18, 2026