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ProDerm ULTRA 4
EUDAMEDClass III (EU MDR)
Ref BPLN2-60JCRef BPLN-60Ref BPLN4-60JCRef BPLN-60JC
Identity
- Trade Name
- ProDerm ULTRA 4 EUDAMED
- Device Name
- ProDerm ULTRA 4 EUDAMED
- Model / Reference
- BPLN2-60JC EUDAMEDBPLN-60 EUDAMEDBPLN4-60JC EUDAMEDBPLN-60JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947981036 EUDAMED08809947980466 EUDAMED08809947981388 EUDAMED08809947980657 EUDAMED
- Basic UDI-DI
- B-08809947981036 EUDAMEDB-08809947980466 EUDAMEDB-08809947981388 EUDAMEDB-08809947980657 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 4 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-08809947981036 | 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 (4)
- EUDAMED 4e408d8a-5e4b-486a-9635-b7d73fc007c2 61 fields · synced Aug 2, 2026
- EUDAMED e648caff-83c8-4e90-81ca-37f702449ed5 61 fields · synced May 18, 2026
- EUDAMED e470f19e-836b-47a7-8d9d-5175ee951e0e 61 fields · synced May 18, 2026
- EUDAMED 0ecf1745-b111-4591-9850-a517c4fb8c72 61 fields · synced May 19, 2026