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BEAUVOUS Sub-Q HA Filler
EUDAMEDClass III (EU MDR)
Ref BPLN4-60BCRef BPLN-60Ref BPLN4-60JCRef BPLN-60BCRef BPLN2-60BC
Identity
- Trade Name
- BEAUVOUS Sub-Q HA Filler EUDAMED
- Device Name
- BEAUVOUS Sub-Q HA Filler EUDAMED
- Model / Reference
- BPLN4-60BC EUDAMEDBPLN-60 EUDAMEDBPLN4-60JC EUDAMEDBPLN-60BC EUDAMEDBPLN2-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639786628 EUDAMED08809639784624 EUDAMED08809639786284 EUDAMED08809639785263 EUDAMED08809639785942 EUDAMED
- Basic UDI-DI
- B-08809639786628 EUDAMEDB-08809639784624 EUDAMEDB-08809639786284 EUDAMEDB-08809639785263 EUDAMEDB-08809639785942 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
BEAUVOUS Sub-Q HA Filler 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-08809639786628 | 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 (5)
- EUDAMED a210ed48-8f2a-49e5-a2a1-d7de5e346a82 61 fields · synced Aug 4, 2026
- EUDAMED 70a0bc90-03e0-464b-a485-f22a288d15ab 61 fields · synced May 17, 2026
- EUDAMED 43945fa3-9125-4458-8ad3-623fb1a8a417 61 fields · synced May 17, 2026
- EUDAMED 622b5b5b-ee7f-47ba-b248-f6c1c5a34cf1 61 fields · synced May 18, 2026
- EUDAMED 44d45c3f-50d1-4084-8c0a-e48829da73dc 61 fields · synced May 19, 2026