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SMART FLOW Kit NIV Large "BLUE"
EUDAMEDClass IIa (EU MDR)
Ref 12898D08Model SMART FLOW Kit NIV Large "BLUE"
by GINEVRI srl
Identity
- Trade Name
- SMART FLOW Kit NIV Large "BLUE" EUDAMED
- Device Name
- SMART FLOW Kit NIV EUDAMED
- Model / Reference
- SMART FLOW Kit NIV Large "BLUE" EUDAMED12898D08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053847360303 EUDAMED
- Basic UDI-DI
- B-08053847360303 EUDAMED
- EMDN Code
- R02010102 BREATHING CIRCUITS, WITH WATER TRAP EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SMART FLOW Kit NIV Large "BLUE" by GINEVRI 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-08053847360303 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GINEVRI srl
- EUDAMED SRN
- IT-MF-000034527
Sources (1)
- EUDAMED 4042c1f6-c14b-497d-b9b6-f8ce3f1a102a 61 fields · synced Jun 19, 2026