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SkinPlus-HYAL Implant
EUDAMEDClass III (EU MDR)
Ref BPLN-100BCRef HYALDEW-JCRef DENEB-BCRef SkinPlus-HYAL 60Ref HYALDEW-BCRef SkinPlus-HYAL 100JCRef BPLN-100Ref SkinPlus-HYAL 100Ref BPLN-100JCRef SkinPlus-HYAL 70Ref DENEB-JC
Identity
- Trade Name
- SkinPlus-HYAL Implant EUDAMED
- Device Name
- SkinPlus-HYAL Implant EUDAMED
- Model / Reference
- BPLN-100BC EUDAMEDHYALDEW-JC EUDAMEDDENEB-BC EUDAMEDSkinPlus-HYAL 60 EUDAMEDHYALDEW-BC EUDAMEDSkinPlus-HYAL 100JC EUDAMEDBPLN-100 EUDAMEDSkinPlus-HYAL 100 EUDAMEDBPLN-100JC EUDAMEDSkinPlus-HYAL 70 EUDAMEDDENEB-JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639783009 EUDAMED08809639784235 EUDAMED08809639784310 EUDAMED08809947984969 EUDAMED08809639784259 EUDAMED08809639784099 EUDAMED08809639782996 EUDAMED08809639784037 EUDAMED08809639781838 EUDAMED08809947984983 EUDAMED08809639784297 EUDAMED
- Basic UDI-DI
- B-08809639783009 EUDAMEDB-08809639784235 EUDAMEDB-08809639784310 EUDAMEDB-08809947984969 EUDAMEDB-08809639784259 EUDAMEDB-08809639784099 EUDAMEDB-08809639782996 EUDAMEDB-08809639784037 EUDAMEDB-08809639781838 EUDAMEDB-08809947984983 EUDAMEDB-08809639784297 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
SkinPlus-HYAL Implant 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-08809639783009 | 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 (11)
- EUDAMED a109612b-eb38-4b4f-9c21-dd6d018f9090 61 fields · synced Sep 17, 2026
- EUDAMED cbe697a4-27fc-4df4-ac32-5921ded37188 61 fields · synced May 16, 2026
- EUDAMED 125a0f8e-2871-495b-8295-9fcf47816902 61 fields · synced May 16, 2026
- EUDAMED 7f8747a3-fc96-4084-8eaa-681199b856f2 61 fields · synced May 17, 2026
- EUDAMED 196ee6eb-669b-487a-acd8-04a825ff2349 61 fields · synced May 17, 2026
- EUDAMED eab2a9ff-29e1-4801-8692-71e0dbadeb1f 61 fields · synced May 17, 2026
- EUDAMED fcd23c6d-03bb-4a26-9dd0-05f48b0cb095 61 fields · synced May 17, 2026
- EUDAMED 45afbd03-4fc7-4bc4-9902-8ef28731a408 61 fields · synced May 17, 2026
- EUDAMED 0b386211-d339-42ed-8fc8-1f1ebff39bc8 61 fields · synced May 18, 2026
- EUDAMED 2504fb63-e3c2-406b-9b33-a3099043302a 61 fields · synced May 18, 2026
- EUDAMED 1c05760c-4870-4a13-afe2-387c041a1446 61 fields · synced May 18, 2026