smART+ Fluid Bag and Nutrition Bag- ENFit Set
Ref CU000-004
Active
CE MDR CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-07290018084311 07290018084311 | Date26 May 2026 | StatusActive |
| European Union | CE/MDD | NumberB-07290018084311 07290018084311 | Date26 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device Name
- smART+ Feeding Set
- Model / Reference
- CU000-004
- Primary DI / UDI-DI
- 07290018084311
- Basic UDI-DI
- B-07290018084311, 7290018084FluidHE
- Direct Marketing DI
- 07290018084311
- EMDN Code
- A03010399 Enteral feeding controllers - other
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IL-MF-000023413
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from ART MEDICAL Ltd.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No