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IPCHE the Premium T
EUDAMEDClass III (EU MDR)
Ref BPL30-60JCRef BPL30-60BCRef BPL30-60
Identity
- Trade Name
- IPCHE the Premium T EUDAMED
- Device Name
- IPCHE the Premium T EUDAMED
- Model / Reference
- BPL30-60JC EUDAMEDBPL30-60BC EUDAMEDBPL30-60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947981708 EUDAMED08809639783436 EUDAMED08809639783429 EUDAMED
- Basic UDI-DI
- B-08809947981708 EUDAMEDB-08809639783436 EUDAMEDB-08809639783429 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
IPCHE the Premium T 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-08809947981708 | 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 92852d19-77f5-445a-b234-a3794ff5602a 61 fields · synced Jul 23, 2026
- EUDAMED 141e74e9-3fe7-4dbd-91d3-ef1fb81157dd 61 fields · synced May 18, 2026
- EUDAMED 413e648f-0038-4e25-8515-db4b78e8c850 61 fields · synced May 19, 2026