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RENAITRE Volume
EUDAMEDClass III (EU MDR)
Ref BPLN-60BCRef BPLN2-60BCModel BPLN2-60BCRef BPLN4-60JCRef BPLN2-60JCRef BPLN-60Ref BPLN-60JC
Identity
- Trade Name
- RENAITRE Volume EUDAMED
- Device Name
- RENAITRE Volume EUDAMED
- Model / Reference
- BPLN-60BC EUDAMEDBPLN2-60BC EUDAMEDBPLN4-60JC EUDAMEDBPLN2-60JC EUDAMEDBPLN-60 EUDAMEDBPLN-60JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947980787 EUDAMED08809639783528 EUDAMED08809947981326 EUDAMED08809947980978 EUDAMED08809947980404 EUDAMED08809947980596 EUDAMED
- Basic UDI-DI
- B-08809947980787 EUDAMEDB-08809639783528 EUDAMEDB-08809947981326 EUDAMEDB-08809947980978 EUDAMEDB-08809947980404 EUDAMEDB-08809947980596 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 Volume 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-08809947980787 | 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 (6)
- EUDAMED 16c79b04-27dc-4bb6-9974-e19e2e22e0bb 61 fields · synced Jul 31, 2026
- EUDAMED 1940b0b9-13a0-40d9-9078-045382b9d970 61 fields · synced May 11, 2026
- EUDAMED 06990e4d-a6f1-4197-9e43-6cecca5f3521 61 fields · synced May 16, 2026
- EUDAMED fdb68969-05cd-479d-8752-3149ecc6ec61 61 fields · synced May 17, 2026
- EUDAMED 05bde87c-3b97-4f39-bbef-9062f5480d91 61 fields · synced May 17, 2026
- EUDAMED 44184b57-5249-4e27-a828-b1e955d61e4f 61 fields · synced May 18, 2026