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Sabrina Superb
EUDAMEDClass III (EU MDR)
Ref BPLN2-60BCModel BPLN2-60BCRef BPLN-60BCRef BPLN2-60JCRef BPLN-60JCRef BPLN4-60JCRef BPLN-60
Identity
- Trade Name
- Sabrina Superb EUDAMED
- Device Name
- Sabrina Superb EUDAMED
- Model / Reference
- BPLN2-60BC EUDAMEDBPLN-60BC EUDAMEDBPLN2-60JC EUDAMEDBPLN-60JC EUDAMEDBPLN4-60JC EUDAMEDBPLN-60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639782552 EUDAMED08809947980893 EUDAMED08809947981081 EUDAMED08809947980701 EUDAMED08809947981432 EUDAMED08809947980510 EUDAMED
- Basic UDI-DI
- B-08809639782552 EUDAMEDB-08809947980893 EUDAMEDB-08809947981081 EUDAMEDB-08809947980701 EUDAMEDB-08809947981432 EUDAMEDB-08809947980510 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
Sabrina Superb 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-08809639782552 | 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 53511da7-f682-4a82-b840-3d7322bd6f93 61 fields · synced Jul 28, 2026
- EUDAMED 5631943d-5fe6-4900-b790-6182bc50a3a7 61 fields · synced May 17, 2026
- EUDAMED feb731c4-22c6-42ef-970c-aa8d61902852 61 fields · synced May 17, 2026
- EUDAMED 5d229ceb-66ab-45d9-a85c-d227fea3ce30 61 fields · synced May 17, 2026
- EUDAMED 7bf42244-6d80-44a4-bab7-0802654eced3 61 fields · synced May 17, 2026
- EUDAMED f965df7d-8a93-45fc-8888-e73614a80184 61 fields · synced May 18, 2026