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Fillus Sub-Q
EUDAMEDClass III (EU MDR)
Ref BPLN-60Ref BPLN4-60BCRef BPLN-60BCRef BPLN4-60JCRef BPLN2-60JCRef BPLN2-60BC
Identity
- Trade Name
- FILLUS SUB-Q EUDAMED
- Device Name
- FILLUS SUB-Q EUDAMED
- Model / Reference
- BPLN-60 EUDAMEDBPLN4-60BC EUDAMEDBPLN-60BC EUDAMEDBPLN4-60JC EUDAMEDBPLN2-60JC EUDAMEDBPLN2-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639784549 EUDAMED08809639786543 EUDAMED08809639785188 EUDAMED08809639786208 EUDAMED08809639785539 EUDAMED08809639785867 EUDAMED
- Basic UDI-DI
- B-08809639784549 EUDAMEDB-08809639786543 EUDAMEDB-08809639785188 EUDAMEDB-08809639786208 EUDAMEDB-08809639785539 EUDAMEDB-08809639785867 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
Fillus Sub-Q 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-08809639784549 | 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 (6)
- EUDAMED 42491d71-e449-4a51-8c6e-63d9c46133b2 61 fields · synced Aug 3, 2026
- EUDAMED 570e7007-dc9f-486e-98bd-ad229eabb1f6 61 fields · synced May 16, 2026
- EUDAMED 72b2ecdb-d57f-4141-9600-2bdef4208fc9 61 fields · synced May 17, 2026
- EUDAMED 40f8d7b5-64c6-4963-8756-08aea11011d2 61 fields · synced May 18, 2026
- EUDAMED c746cadc-d744-493b-a834-aa49178b121d 61 fields · synced May 18, 2026
- EUDAMED 44d142cb-6203-4404-9e3e-9a3fcc31baef 61 fields · synced May 19, 2026