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Kbelle ULTRA
EUDAMEDClass III (EU MDR)
Ref BPLN4-60JCRef BPLN-60JCRef BPLN-60BCRef BPLN2-60BC
Identity
- Trade Name
- Kbelle ULTRA EUDAMED
- Device Name
- Kbelle ULTRA EUDAMED
- Model / Reference
- BPLN4-60JC EUDAMEDBPLN-60JC EUDAMEDBPLN-60BC EUDAMEDBPLN2-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947981371 EUDAMED08809947980640 EUDAMED08809947980831 EUDAMED08809947981203 EUDAMED
- Basic UDI-DI
- B-08809947981371 EUDAMEDB-08809947980640 EUDAMEDB-08809947980831 EUDAMEDB-08809947981203 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
Kbelle ULTRA 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-08809947981371 | 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 baf9168d-b66a-47aa-a81e-ecdbef319ac0 61 fields · synced Aug 3, 2026
- EUDAMED 5a17d1e4-128c-4c7b-abae-3604bcfc21f8 61 fields · synced May 17, 2026
- EUDAMED 0eaa3612-6e86-4d8d-ad68-cd46da3801aa 61 fields · synced May 19, 2026
- EUDAMED 08d75fbc-f32f-4961-bcca-7cb463a06322 61 fields · synced May 19, 2026