Infusion set
by Sunrise Medical Co., Ltd. 43 variants
Ref IV02W/200Model IV01 DF/180, IV02,IV02W,IV02W/A,IV02W/RF,IV02W/Y,IV02W/NF,IV02W/FR,IV02W/VF,IV02W/MF,IV02W/3W,IV02/IVC 2W NDF/200R
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 | Number697565568DIS001QQ 06975655680676 | 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- Withdrawn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 DF/180, IV02W/200, IV02, IV02W, IV02W/A, IV02W/RF, IV02W/Y, IV02W/NF, IV02W/FR, IV02W/VF, IV02W/MF, IV02W/3W, IV02/IVC 2W NDF/200R
- Primary DI / UDI-DI
- 06975655680676
- Basic UDI-DI
- 697565568DIS001QQ, 697565568DIS006R2
- 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