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Extra Ⅱ
EUDAMEDClass III (EU MDR)
Ref BPLN3-27JCRef BPLN-27Ref BPLN-27BCRef BPLN3-27BC
Identity
- Trade Name
- EXTRA Ⅱ EUDAMED
- Device Name
- EXTRA Ⅱ EUDAMED
- Model / Reference
- BPLN3-27JC EUDAMEDBPLN-27 EUDAMEDBPLN-27BC EUDAMEDBPLN3-27BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639788059 EUDAMED08809639787113 EUDAMED08809639787731 EUDAMED08809639788387 EUDAMED
- Basic UDI-DI
- B-08809639788059 EUDAMEDB-08809639787113 EUDAMEDB-08809639787731 EUDAMEDB-08809639788387 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
Extra Ⅱ 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-08809639788059 | 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 70cd0531-ac8c-426c-b7a5-12eefe4792b2 61 fields · synced Jul 19, 2026
- EUDAMED 4970cc24-1e56-4623-b699-43360f1058c2 61 fields · synced May 18, 2026
- EUDAMED 28484f23-848b-4c96-8054-291eddb5ca5b 61 fields · synced May 18, 2026
- EUDAMED dd4815ff-b5aa-4f0c-950b-66bc0cc0890c 61 fields · synced May 18, 2026