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BLACK ROSE by zishel xcharge S
EUDAMEDClass III (EU MDR)
Ref BPL100-27CRef BPL100-27BC
Identity
- Trade Name
- BLACK ROSE by zishel xcharge S EUDAMED
- Device Name
- BLACK ROSE by zishel xcharge S EUDAMED
- Model / Reference
- BPL100-27C EUDAMEDBPL100-27BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947983412 EUDAMED08809947983535 EUDAMED
- Basic UDI-DI
- B-08809947983412 EUDAMEDB-08809947983535 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
BLACK ROSE by zishel xcharge S 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-08809947983412 | 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 831d21a1-0406-4561-bbfc-783690179487 61 fields · synced Jul 12, 2026
- EUDAMED 8b676cac-f0c5-4a68-a6c8-64d47f12955b 61 fields · synced May 18, 2026