Volumed Sideline
Ref 5804801211Model Dispositivi per Infusione ed Aspirazione
Active
CE MDR
Valid until
13 Feb 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805274795INFNN 08052747958849 | Date15 May 2024 | StatusActive |
Certificates
- 0425-MDR-030019-04 Active
Quality management system EU MDR
- Certifier
- ICIM S.P.A. 0425
- Issued
- 23 Jul 2026
- Expires
- 13 Feb 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- Dispositivi per Infusione ed Aspirazione, 5804801211
- Primary DI / UDI-DI
- 08052747958849
- Basic UDI-DI
- 805274795INFNN
- EMDN code
- A03010101 Infusion controllers with or w/o air inlet
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000023426
Other devices from Phoenix S.R.L.
Properties
Other properties (12)
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Measuring function: No
- Incorporates a medicinal substance: No