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VivaFoam™
EUDAMEDClass IIb (EU MDR)
Ref PDI600305Model VivaFoam™ Filler 15x10x1.5
by Sunmedic AB
Identity
- Trade Name
- VivaFoam™ EUDAMED
- Device Name
- VivaFoam™ Wound Filler EUDAMED
- Model / Reference
- VivaFoam™ Filler 15x10x1.5 EUDAMEDPDI600305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17350127833051 EUDAMED
- Basic UDI-DI
- B-17350127833051 EUDAMED
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
VivaFoam™ by Sunmedic AB — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
- ALIVIOVISCO — LIDERMED S.A. · Class I
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- Polyurethane Foam Dressing — Shandong Shinrise Medical Supplies Co., Ltd. · Class IIa
- Holland & Barrett Eczeem crème — PK Benelux BV · Class IIa
- Paraffin gauze dressings — Roosin Medical Co., Ltd. · Class IIa
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-17350127833051 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sunmedic AB
- EUDAMED SRN
- SE-MF-000012997
Sources (1)
- EUDAMED b058dcca-ec7f-4f65-80f2-6f90ef642405 61 fields · synced Oct 6, 2026