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HyalDew Fine
EUDAMEDClass III (EU MDR)
Ref BPL-27JCRef BPLN-30Ref BPLN-30BCRef BPL20-27BCRef BPL-27BCRef BPLN-30JC
Identity
- Trade Name
- HyalDew Fine EUDAMED
- Device Name
- HyalDew Fine EUDAMED
- Model / Reference
- BPL-27JC EUDAMEDBPLN-30 EUDAMEDBPLN-30BC EUDAMEDBPL20-27BC EUDAMEDBPL-27BC EUDAMEDBPLN-30JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639789599 EUDAMED08809639783245 EUDAMED08809639783252 EUDAMED08809639789698 EUDAMED08809639789636 EUDAMED08809639781661 EUDAMED
- Basic UDI-DI
- B-08809639789599 EUDAMEDB-08809639783245 EUDAMEDB-08809639783252 EUDAMEDB-08809639789698 EUDAMEDB-08809639789636 EUDAMEDB-08809639781661 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 Fine 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-08809639789599 | 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 (6)
- EUDAMED 7484f7f9-8ebc-403d-ac92-afb3ac9d6cb2 61 fields · synced Sep 17, 2026
- EUDAMED 432545cb-e4d5-4adc-a6d2-b3e323d2c24f 61 fields · synced May 17, 2026
- EUDAMED 7e232f8c-cdea-4cfd-948e-814d0ec1a638 61 fields · synced May 18, 2026
- EUDAMED 599e65af-36f6-47f7-a0d3-f4716d03891b 61 fields · synced May 18, 2026
- EUDAMED 7d1074b2-ec66-4bd3-af68-b4a71f449fea 61 fields · synced May 18, 2026
- EUDAMED cb8b8221-9acc-4386-9019-26eae4f989c5 61 fields · synced May 19, 2026