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VivereX™
EUDAMEDClass IIb (EU MDR)
Ref PDI600121Model VivereX™ Pump + 2 FC Dressings 10x20
by Sunmedic AB
Identity
- Trade Name
- VivereX™ EUDAMED
- Device Name
- VivereX™ NPWT System EUDAMED
- Model / Reference
- VivereX™ Pump + 2 FC Dressings 10x20 EUDAMEDPDI600121 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 27350127831214 EUDAMED
- Basic UDI-DI
- B-27350127831214 EUDAMED
- EMDN Code
- M04040702,Z12019003 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-27350127831214 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sunmedic AB
- EUDAMED SRN
- SE-MF-000012997
Sources (1)
- EUDAMED 4cb10cd3-8f2c-4bc3-a066-e15ec787dbec 61 fields · synced Oct 6, 2026