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Filerah MID
EUDAMEDClass III (EU MDR)
Ref BPLN-27JCRef BPLN3-27JCRef BPLN-27Ref BPLN3-27BC
Identity
- Trade Name
- Filerah MID EUDAMED
- Device Name
- Filerah MID EUDAMED
- Model / Reference
- BPLN-27JC EUDAMEDBPLN3-27JC EUDAMEDBPLN-27 EUDAMEDBPLN3-27BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639787496 EUDAMED08809639788110 EUDAMED08809639787175 EUDAMED08809639788448 EUDAMED
- Basic UDI-DI
- B-08809639787496 EUDAMEDB-08809639788110 EUDAMEDB-08809639787175 EUDAMEDB-08809639788448 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
Filerah 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-08809639787496 | 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 f694cd15-1924-417a-9603-05287639cc50 61 fields · synced Jul 29, 2026
- EUDAMED 06a2520f-d064-4b4e-a07e-b1fabec9e901 61 fields · synced May 16, 2026
- EUDAMED 86f5d607-5656-4ee7-a2c1-295a682dbf1d 61 fields · synced May 17, 2026
- EUDAMED 64a9af8a-7dde-4593-a282-8e7ea000c951 61 fields · synced May 18, 2026