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Sabrina Standard
EUDAMEDClass III (EU MDR)
Ref BPLN3-27JCRef BPLN3-27BCRef BPLN-27Ref BPLN-27BC
Identity
- Trade Name
- Sabrina Standard EUDAMED
- Device Name
- Sabrina Standard EUDAMED
- Model / Reference
- BPLN3-27JC EUDAMEDBPLN3-27BC EUDAMEDBPLN-27 EUDAMEDBPLN-27BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947982606 EUDAMED08809947982781 EUDAMED08809947982088 EUDAMED08809639782576 EUDAMED
- Basic UDI-DI
- B-08809947982606 EUDAMEDB-08809947982781 EUDAMEDB-08809947982088 EUDAMEDB-08809639782576 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany 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 Standard 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-08809947982606 | 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 c0ea129e-17fd-4b77-aa51-92569ed7f5c1 61 fields · synced Jul 15, 2026
- EUDAMED 4660689b-89b9-4c74-bc39-23ada7db90e0 61 fields · synced May 17, 2026
- EUDAMED c2ec2f8f-07eb-4626-a713-ff47999c0b09 61 fields · synced May 18, 2026
- EUDAMED 4bd8abf7-e5f8-4f65-a6b6-4ffaa59f7657 61 fields · synced May 18, 2026