← Back to catalogue
Selkiee Fine
EUDAMEDClass III (EU MDR)
Ref BPLN-30BCModel BPLN-30BCRef BPLN-30JCRef BPLN-30
Identity
- Trade Name
- SELKIEE FINE EUDAMED
- Device Name
- SELKIEE FINE EUDAMED
- Model / Reference
- BPLN-30BC EUDAMEDBPLN-30JC EUDAMEDBPLN-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947983979 EUDAMED08809947983962 EUDAMED08809947983955 EUDAMED
- Basic UDI-DI
- B-08809947983979 EUDAMEDB-08809947983962 EUDAMEDB-08809947983955 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMEDTürkiye 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
Selkiee Fine 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-08809947983979 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioPlus Co., Ltd.
- EUDAMED SRN
- KR-MF-000008618
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (3)
- EUDAMED d37f6da5-50ed-4d68-9b49-355cf787b4bc 61 fields · synced Jul 19, 2026
- EUDAMED 2ea779ee-26fe-4123-b620-68b241728c3d 61 fields · synced May 18, 2026
- EUDAMED e3934c6a-b086-46ce-8d41-ccb5be4eed2d 61 fields · synced May 19, 2026