Identity
- Trade Name
- HyalDew Mid EUDAMED
- Device Name
- HyalDew Mid EUDAMED
- Model / Reference
- BPLN-27JC EUDAMEDBPLN3-27JC EUDAMEDBPLN-27BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639781647 EUDAMED08809639787953 EUDAMED08809639781128 EUDAMED08809639783153 EUDAMED
- Basic UDI-DI
- B-08809639781647 EUDAMEDB-08809639787953 EUDAMEDB-08809639781128 EUDAMEDB-08809639783153 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
HyalDew Mid 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-08809639781647 | 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 7be8519b-3c78-420c-9b94-c7fbff66aa39 61 fields · synced Jul 17, 2026
- EUDAMED 671fada6-071f-4da2-bc6c-de0ac412cae9 61 fields · synced May 17, 2026
- EUDAMED a2bd80a3-2618-409e-b0b8-6b8536e014b0 61 fields · synced May 17, 2026
- EUDAMED f5d36fb7-75b0-4299-b47e-3713d3d98026 61 fields · synced May 19, 2026