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Rejunos Hard
EUDAMEDClass III (EU MDR)
Ref BPLN2-60BCRef BPLN-60BCRef BPLN4-60JCRef BPLN2-60JCRef BPLN-60JCRef BPLN4-60BC
Identity
- Trade Name
- REJUNOS HARD EUDAMED
- Device Name
- REJUNOS HARD EUDAMED
- Model / Reference
- BPLN2-60BC EUDAMEDBPLN-60BC EUDAMEDBPLN4-60JC EUDAMEDBPLN2-60JC EUDAMEDBPLN-60JC EUDAMEDBPLN4-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639782675 EUDAMED08809639782651 EUDAMED08809639782682 EUDAMED08809639782668 EUDAMED08809639782644 EUDAMED08809639782699 EUDAMED
- Basic UDI-DI
- B-08809639782675 EUDAMEDB-08809639782651 EUDAMEDB-08809639782682 EUDAMEDB-08809639782668 EUDAMEDB-08809639782644 EUDAMEDB-08809639782699 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
Rejunos 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-08809639782675 | 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 0c27cd96-6278-4554-b293-0a54572844be 61 fields · synced Jul 29, 2026
- EUDAMED 0a445848-69e8-4f54-93fb-3dcef10049f4 61 fields · synced May 17, 2026
- EUDAMED e0898251-b1b9-4fed-8663-0fc26c6bdefe 61 fields · synced May 17, 2026
- EUDAMED 094cefe7-7b71-4fbb-88b3-6995737b2f3e 61 fields · synced May 17, 2026
- EUDAMED 35b2e412-ef17-4736-8093-d35c01dd4749 61 fields · synced May 17, 2026
- EUDAMED 89b8a478-fdab-4957-bcd3-8786124d997f 61 fields · synced May 19, 2026