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Set Therapie Pression Negative
EUDAMEDClass IIa (EU MDR)
Ref 9106_B
by Hemodia Sas
Identity
- Trade Name
- SET THERAPIE PRESSION NEGATIVE EUDAMED
- Device Name
- Assemblage SUTURE & PLAIES STE EUDAMED
- Model / Reference
- 9106_B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661379270523 EUDAMED
- Basic UDI-DI
- 3661379ASS25SUT2AUC EUDAMED
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Les assemblages de la gamme ‘Sutures & Plaies » sont destinés à : Être utilisés pour la prise en charge la suture et le soin des plaies ou l'entretien de tout type de dispositif nécessitant des soins répétés (ex: trachéotomie, TPN …) EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Scar-management dressing, reusable
Set Therapie Pression Negative by Hemodia Sas — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Scar-management dressing, reusable.
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- THERAFOAM — BIODERMIS LLC · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3661379ASS25SUT2AUC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hemodia Sas
- EUDAMED SRN
- FR-PR-000007189
Sources (1)
- EUDAMED cfa13b7c-50d3-4b17-bb8f-bdabee03fe38 61 fields · synced Jun 19, 2026