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Elravie Ultra Volume Plus 2mL
EUDAMEDClass III (EU MDR)
Ref Elravie Ultra Volume Plus 2mLModel Sterile Injectable Dermal Filler
by Humedix
Identity
- Trade Name
- Elravie Ultra Volume Plus 2mL EUDAMED
- Model / Reference
- Sterile Injectable Dermal Filler EUDAMEDElravie Ultra Volume Plus 2mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809162254595 EUDAMED
- Basic UDI-DI
- B-08809162254595 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
Elravie Ultra Volume Plus 2mL by Humedix — 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-08809162254595 | Class III | Active |
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Manufacturer
- Manufacturer
- Humedix
- EUDAMED SRN
- KR-MF-000030230
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 865e6c9b-b3b0-4db5-a6c3-c06407d2e641 61 fields · synced Jun 18, 2026