Infusion set
by Sunrise Medical Co., Ltd. 43 variants
Ref IV01/AF180Model IV01,IV01W,IV01W/A,IV01W/RF,IV01W/Y,IV01W/NF,IV01W/FR,IV01W/VF,IV01/3W,IV01W/MF
Active
CE MDR
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 | Number697565568IV01/AF180UT 06975655681505 | Date22 Apr 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- Withdrawn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 Active
Specification
- Trade Name
- Infusion setPrzyrzad do infuzji
- Device Name
- Disposable Infusion Sets
- Model / Reference
- IV01/AF180, IV01, IV01W, IV01W/A, IV01W/RF, IV01W/Y, IV01W/NF, IV01W/FR, IV01W/VF, IV01/3W, IV01W/MF
- Primary DI / UDI-DI
- 06975655681505
- Basic UDI-DI
- 697565568IV01/AF180UT, 697565568IV01WSF
- EMDN Code
- A03010101 Infusion controllers with or w/o air inlet
- Device Class
- Class I
- Market of Registration
- GermanyPoland
Manufacturer details
- EUDAMED SRN
- CN-MF-000029852
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Sunrise Medical Co., Ltd.
Properties
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No