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Nimfia Volume
EUDAMEDClass III (EU MDR)
Ref BPLN2-60JCRef BPLN-60BCRef BPLN4-60BC
Identity
- Trade Name
- Nimfia Volume EUDAMED
- Device Name
- Nimfia Volume EUDAMED
- Model / Reference
- BPLN2-60JC EUDAMEDBPLN-60BC EUDAMEDBPLN4-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947981005 EUDAMED08809947980817 EUDAMED08809947981548 EUDAMED
- Basic UDI-DI
- B-08809947981005 EUDAMEDB-08809947980817 EUDAMEDB-08809947981548 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
Nimfia 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-08809947981005 | 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 a5332a18-410f-4ca5-9b81-e391c4721793 61 fields · synced Jul 26, 2026
- EUDAMED 9d56727f-60b8-4a9d-9c3b-d216c8d85a5b 61 fields · synced May 18, 2026
- EUDAMED 2613d723-7733-47ef-8c14-3522fb6e01e9 61 fields · synced May 18, 2026