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ProDerm ULTRA 3
EUDAMEDClass III (EU MDR)
Ref BPLN-27BCRef BPLN3-27JCRef BPLN-27Ref BPLN-27JCRef BPLN3-27BC
Identity
- Trade Name
- ProDerm ULTRA 3 EUDAMED
- Device Name
- ProDerm ULTRA 3 EUDAMED
- Model / Reference
- BPLN-27BC EUDAMEDBPLN3-27JC EUDAMEDBPLN-27 EUDAMEDBPLN-27JC EUDAMEDBPLN3-27BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947982385 EUDAMED08809947982552 EUDAMED08809947982033 EUDAMED08809947982217 EUDAMED08809947982736 EUDAMED
- Basic UDI-DI
- B-08809947982385 EUDAMEDB-08809947982552 EUDAMEDB-08809947982033 EUDAMEDB-08809947982217 EUDAMEDB-08809947982736 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
ProDerm ULTRA 3 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-08809947982385 | 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 (5)
- EUDAMED 261fe1ad-7248-4de8-9f41-810cfff33be9 61 fields · synced Jul 14, 2026
- EUDAMED d9556fc7-3469-4ac0-9576-9efcf46a0659 61 fields · synced May 17, 2026
- EUDAMED 052417fa-82f8-4305-aa8a-37c00dd1067f 61 fields · synced May 17, 2026
- EUDAMED ad8c56ae-bd61-431d-aa88-19e321df20ac 61 fields · synced May 18, 2026
- EUDAMED b9a8981f-824a-4d3c-afd2-752db5b87ade 61 fields · synced May 18, 2026