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Kbelle MID
EUDAMEDClass III (EU MDR)
Ref BPLN-27JCRef BPLN3-27BCRef BPLN-27Ref BPLN3-27JC
Identity
- Trade Name
- Kbelle MID EUDAMED
- Device Name
- Kbelle MID EUDAMED
- Model / Reference
- BPLN-27JC EUDAMEDBPLN3-27BC EUDAMEDBPLN-27 EUDAMEDBPLN3-27JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947982200 EUDAMED08809947982729 EUDAMED08809947982026 EUDAMED08809947982545 EUDAMED
- Basic UDI-DI
- B-08809947982200 EUDAMEDB-08809947982729 EUDAMEDB-08809947982026 EUDAMEDB-08809947982545 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 MID 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-08809947982200 | 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 7a98d427-b020-47f2-9c42-f4ae2a264a5c 61 fields · synced Jul 24, 2026
- EUDAMED 2aa6fb36-4f08-4552-9a12-2340047763e8 61 fields · synced May 17, 2026
- EUDAMED 34458bca-d21d-4fee-8312-626fb82bb903 61 fields · synced May 18, 2026
- EUDAMED e3ddaddf-f52f-4ded-9794-cff9c5025924 61 fields · synced May 18, 2026