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Revite Shape
EUDAMEDClass III (EU MDR)
Ref BPLN2-60JCRef BPLN-60BCRef BPLN4-60BC
Identity
- Trade Name
- Revite Shape EUDAMED
- Device Name
- Revite Shape EUDAMED
- Model / Reference
- BPLN2-60JC EUDAMEDBPLN-60BC EUDAMEDBPLN4-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639785522 EUDAMED08809639782149 EUDAMED08809639786536 EUDAMED
- Basic UDI-DI
- B-08809639785522 EUDAMEDB-08809639782149 EUDAMEDB-08809639786536 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
Revite Shape 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-08809639785522 | 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 5c4fc434-dfb8-4ed7-a67a-58082a53c419 61 fields · synced Jul 27, 2026
- EUDAMED 08ed78e4-fb19-4855-b57d-ceb3e2bd2f80 61 fields · synced May 17, 2026
- EUDAMED 51aac744-8f98-4809-b992-6bbf0aa560ed 61 fields · synced May 18, 2026