Ambix nova
by Fresenius Kabi AG 24 variants
Ref N044549
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4052682AIV02012bCF000ADF 04052682067693 | Date23 Oct 2026 | StatusActive |
Official records
- EUDAMED public site 4052682AIV02012bCF000ADF
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- Withdrawn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
- Device name
- Volumetric Infusion Pump Infusion Instrument
- Model / reference
- N044549
- Primary DI / UDI-DI
- 04052682067693
- Basic UDI-DI
- 4052682AIV02012bCF000ADF
- EMDN code
- Z12030301 Infusion pumps
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000009273
Other devices from Fresenius Kabi
Properties
Other properties (13)
- Supplied sterile: No
- 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