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ReMedium Sub-Q
EUDAMEDClass III (EU MDR)
Ref BPLN2-60BCRef BPLN-60BCRef BPLN4-60JCRef BPLN4-60BC
Identity
- Trade Name
- ReMedium Sub-Q EUDAMED
- Device Name
- ReMedium Sub-Q EUDAMED
- Model / Reference
- BPLN2-60BC EUDAMEDBPLN-60BC EUDAMEDBPLN4-60JC EUDAMEDBPLN4-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639785911 EUDAMED08809639785232 EUDAMED08809639786253 EUDAMED08809639786598 EUDAMED
- Basic UDI-DI
- B-08809639785911 EUDAMEDB-08809639785232 EUDAMEDB-08809639786253 EUDAMEDB-08809639786598 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
ReMedium 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-08809639785911 | 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 1b4c659b-5fa4-42cf-acc4-9eaf9a851c91 61 fields · synced Jul 26, 2026
- EUDAMED c9669cf1-85b0-4ad0-9d6c-c6db5f2afe58 61 fields · synced May 17, 2026
- EUDAMED 96788d8e-4041-4f2d-9dc2-fbbefa427f6c 61 fields · synced May 17, 2026
- EUDAMED 9c290724-728b-4b05-bc89-786e064ea0a6 61 fields · synced May 17, 2026