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Wellstox Plus Volume
EUDAMEDClass III (EU MDR)
Ref BPLN-60JCRef BPLN2-60JCRef BPLN4-60BCRef BPLN2-60BCRef BPLN-60BCRef BPLN-60
Identity
- Trade Name
- Wellstox Plus Volume EUDAMED
- Device Name
- Wellstox Plus Volume EUDAMED
- Model / Reference
- BPLN-60JC EUDAMEDBPLN2-60JC EUDAMEDBPLN4-60BC EUDAMEDBPLN2-60BC EUDAMEDBPLN-60BC EUDAMEDBPLN-60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947980671 EUDAMED08809947981050 EUDAMED08809947981593 EUDAMED08809947981234 EUDAMED08809947980862 EUDAMED08809947980480 EUDAMED
- Basic UDI-DI
- B-08809947980671 EUDAMEDB-08809947981050 EUDAMEDB-08809947981593 EUDAMEDB-08809947981234 EUDAMEDB-08809947980862 EUDAMEDB-08809947980480 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
Wellstox Plus 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-08809947980671 | 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 88b7e3a3-2848-479a-ace3-c1e96e8daa29 61 fields · synced Sep 17, 2026
- EUDAMED f6ae45f6-b7b3-4860-8587-5853eaa40a1b 61 fields · synced May 17, 2026
- EUDAMED 0c6627ff-9626-45a2-a732-71eba00d8a22 61 fields · synced May 17, 2026
- EUDAMED 85776645-36f7-40b6-9524-db90940d01c7 61 fields · synced May 17, 2026
- EUDAMED 50ea3312-bfd3-4bcf-8ff9-22f0fe23cd8c 61 fields · synced May 18, 2026
- EUDAMED a21497d1-fe23-4f2a-9396-94cb71c8b142 61 fields · synced May 19, 2026