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HyalDew All
EUDAMEDClass III (EU MDR)
Ref BPLN-60BCRef BPLN2-60BCRef BPLN-60Ref BPL20-60BCRef BPLN4-60BCRef BPL20-60JCRef BPLN2-60JC
Identity
- Trade Name
- HyalDew All EUDAMED
- Device Name
- HyalDew All EUDAMED
- Model / Reference
- BPLN-60BC EUDAMEDBPLN2-60BC EUDAMEDBPLN-60 EUDAMEDBPL20-60BC EUDAMEDBPLN4-60BC EUDAMEDBPL20-60JC EUDAMEDBPLN2-60JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639783047 EUDAMED08809639783054 EUDAMED08809639783030 EUDAMED08809639783092 EUDAMED08809639783061 EUDAMED08809639786772 EUDAMED08809639785386 EUDAMED
- Basic UDI-DI
- B-08809639783047 EUDAMEDB-08809639783054 EUDAMEDB-08809639783030 EUDAMEDB-08809639783092 EUDAMEDB-08809639783061 EUDAMEDB-08809639786772 EUDAMEDB-08809639785386 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 All 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-08809639783047 | 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 (7)
- EUDAMED d94005fa-359c-4802-90a4-647666003188 61 fields · synced Aug 1, 2026
- EUDAMED e3cdfccb-aa93-402c-96fc-288cd0d14fbc 61 fields · synced May 17, 2026
- EUDAMED bcefe2b7-454c-4c7e-8cd1-566b283d07e8 61 fields · synced May 17, 2026
- EUDAMED ac83c429-c263-41a8-9920-4e1b5a5aed0e 61 fields · synced May 18, 2026
- EUDAMED 2c9f74ca-3ddc-4e63-883d-b108567ee278 61 fields · synced May 18, 2026
- EUDAMED 3478e670-7239-4778-90cc-c0d89c17185c 61 fields · synced May 19, 2026
- EUDAMED 3c379955-10aa-4b30-b8e4-17230b3c833b 61 fields · synced May 19, 2026