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Infini Premium Filler V10
EUDAMEDClass III (EU MDR)
Ref Not applicableModel INFINI PREMIUM FILLER V10
Identity
- Trade Name
- INFINI PREMIUM FILLER V10 EUDAMED
- Device Name
- Sterile Absorbable Poly-L-Lactic acid (PLLA) Dermal Filler EUDAMED
- Model / Reference
- INFINI PREMIUM FILLER V10 EUDAMEDNot applicable EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800125100379 EUDAMED
- Basic UDI-DI
- B-08800125100379 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland 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
Infini Premium Filler V10 by PRP Science 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-08800125100379 | Class III | Active |
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Manufacturer
- Manufacturer
- PRP Science Co., Ltd.
- EUDAMED SRN
- KR-MF-000014450
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (1)
- EUDAMED cfba0349-9815-40fc-af99-991a43ab2e25 61 fields · synced Jun 20, 2026