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Infuset
EUDAMEDClass IIa (EU MDR)
Ref IS464099-ORef IS464097-ORef IS354585-ORef IS154668-ORef IS164098-ORef IS354583-O
Identity
- Trade Name
- INFUSET EUDAMED
- Device Name
- INFUSET - Deflussore per misurazione pressione venosa EUDAMEDINFUSET - Deflussore per CVP EUDAMEDINFUSET - Deflussore macrogoccia PVC-free EUDAMEDINFUSET - Deflussore per pompa MP60 EUDAMEDINFUSET - Deflussore con LLM EUDAMEDINFUSET - Set infusione 2 vie per pompa in PP EUDAMED
- Model / Reference
- IS464099-O EUDAMEDIS464097-O EUDAMEDIS354585-O EUDAMEDIS154668-O EUDAMEDIS164098-O EUDAMEDIS354583-O EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-IS464099-OH3 EUDAMED08049033199611 EUDAMEDD-IS354585-OGT EUDAMEDD-IS154668-OFZ EUDAMED08049033196467 EUDAMEDD-IS354583-OGH EUDAMED
- Basic UDI-DI
- B-IS464099-OH3 EUDAMEDB-08049033199611 EUDAMEDB-IS354585-OGT EUDAMEDB-IS154668-OFZ EUDAMEDB-08049033196467 EUDAMEDB-IS354583-OGH EUDAMED
- EMDN Code
- A03010101 INFUSION CONTROLLERS WITH OR W/O AIR INLET EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Italy 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
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infuset by Know Medical Srl — Class IIa — 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-IS464099-OH3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Know Medical Srl
- EUDAMED SRN
- IT-MF-000013457
Sources (6)
- EUDAMED 94df0469-02bb-4164-8102-1c9f1799829d 61 fields · synced Aug 3, 2026
- EUDAMED c7a1286b-3ab2-4dfd-b89f-36ecdf234894 61 fields · synced May 16, 2026
- EUDAMED 3dbed7fb-a33d-4897-9e2f-1bf270a3331c 61 fields · synced May 17, 2026
- EUDAMED 213f7eba-61a1-41fb-a81d-0b5a41203c15 61 fields · synced May 18, 2026
- EUDAMED dca05f8c-e5f5-43c3-b427-98aa5f13ff9d 61 fields · synced May 18, 2026
- EUDAMED 1712b3f5-35b2-4118-936c-f81d0f54fc65 61 fields · synced Jun 20, 2026