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RENAITRE Classique
EUDAMEDClass III (EU MDR)
Ref BPLN-27Ref BPLN3-27JCRef BPLN-27BC
Identity
- Trade Name
- RENAITRE Classique EUDAMED
- Device Name
- RENAITRE Classique EUDAMED
- Model / Reference
- BPLN-27 EUDAMEDBPLN3-27JC EUDAMEDBPLN-27BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947981975 EUDAMED08809947982491 EUDAMED08809639783535 EUDAMED
- Basic UDI-DI
- B-08809947981975 EUDAMEDB-08809947982491 EUDAMEDB-08809639783535 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany 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
RENAITRE Classique 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-08809947981975 | 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 78a7da91-acf0-415c-8df4-cfadef0988d9 61 fields · synced Jul 30, 2026
- EUDAMED 87297c65-97bb-46fa-93fd-ae9698284504 61 fields · synced May 17, 2026
- EUDAMED 1bce5ba4-8058-4d62-8a2d-983f3809c3f3 61 fields · synced May 18, 2026