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Myfill Ultra
EUDAMEDClass III (EU MDR)
Ref BPLN2-60BCRef BPLN4-60JCRef BPLN4-60BCRef BPLN-60JC
Identity
- Trade Name
- Myfill Ultra EUDAMED
- Device Name
- Myfill Ultra EUDAMED
- Model / Reference
- BPLN2-60BC EUDAMEDBPLN4-60JC EUDAMEDBPLN4-60BC EUDAMEDBPLN-60JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947981173 EUDAMED08809947981340 EUDAMED08809947981531 EUDAMED08809947980619 EUDAMED
- Basic UDI-DI
- B-08809947981173 EUDAMEDB-08809947981340 EUDAMEDB-08809947981531 EUDAMEDB-08809947980619 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
Myfill 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-08809947981173 | 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 a41033ea-7d9a-4404-9380-b69493fa0bac 61 fields · synced Aug 3, 2026
- EUDAMED de6de08b-1d2d-4656-b35e-9fb96fdce5b5 61 fields · synced May 17, 2026
- EUDAMED 3184b30a-3dd1-44cb-8e53-b28054bb707b 61 fields · synced May 17, 2026
- EUDAMED ff4744d2-220a-46c8-baca-b24a08810168 61 fields · synced May 17, 2026