RoweSpike II SV
by RoweMed AG - Medical 4 Life EUDAMED
Active
Ref A-6445
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number42503476SPIKEKY | Date4 Apr 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Spike
- Model / Reference
- A-6445
- Primary DI / UDI-DI
- 04250347604744
- Basic UDI-DI
- 42503476SPIKEKY
- EMDN Code
- A0704 Systems for reconstitution and administration of pharmaceuticals
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005350
Other devices from RoweMed AG - Medical 4 Life
Properties
Other properties (12)
- 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