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Wellstox Plus Light
EUDAMEDClass III (EU MDR)
Ref BPLN-30Ref BPLN-30JCRef BPLN-30BC
Identity
- Trade Name
- Wellstox Plus Light EUDAMED
- Device Name
- Wellstox Plus Light EUDAMED
- Model / Reference
- BPLN-30 EUDAMEDBPLN-30JC EUDAMEDBPLN-30BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947982934 EUDAMED08809947983115 EUDAMED08809947983283 EUDAMED
- Basic UDI-DI
- B-08809947982934 EUDAMEDB-08809947983115 EUDAMEDB-08809947983283 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 Light 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-08809947982934 | 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 96469896-e3f8-48c2-847c-29113222fd95 61 fields · synced Jul 25, 2026
- EUDAMED e7256cfb-4e90-41b5-a9a1-7d0a637a9e66 61 fields · synced May 18, 2026
- EUDAMED ee7ac2f4-0a78-4831-9786-43bb0282a08d 61 fields · synced May 18, 2026