Identity
- Trade Name
- EXTRA H EUDAMED
- Device Name
- EXTRA H EUDAMED
- Model / Reference
- BPL100-60C EUDAMEDBPL100-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639786802 EUDAMED08809639786925 EUDAMED
- Basic UDI-DI
- B-08809639786802 EUDAMEDB-08809639786925 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 H 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-08809639786802 | 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 (2)
- EUDAMED edcc097b-4c44-4902-ae8c-4018f2bc86f5 61 fields · synced Jul 25, 2026
- EUDAMED 730b736e-f250-4933-b70c-c4ed92949911 61 fields · synced May 17, 2026