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VivereX™
EUDAMEDClass IIb (EU MDR)
Ref PDI600224Model VivereX™ Dressing FC 16x16
by Sunmedic AB
Identity
- Trade Name
- VivereX™ EUDAMED
- Device Name
- VivereX™ NPWT Dressing EUDAMED
- Model / Reference
- VivereX™ Dressing FC 16x16 EUDAMEDPDI600224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17350127832245 EUDAMED
- Basic UDI-DI
- B-17350127832245 EUDAMED
- EMDN Code
- M04040702 SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES 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
VivereX™ by Sunmedic AB — Class IIb — 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-17350127832245 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sunmedic AB
- EUDAMED SRN
- SE-MF-000012997
Sources (1)
- EUDAMED f210d301-c204-455f-8610-7287283c4ba4 61 fields · synced Oct 6, 2026