Urine Strip 10ME
Active
Ref Z10010ME/BOX
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-Z10010ME/BOXVC | Date24 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Urine Strip 10ME
- Model / Reference
- Z10010ME/BOX
- Primary DI / UDI-DI
- D-Z10010ME/BOXVC
- Basic UDI-DI
- B-Z10010ME/BOXVC
- EMDN Code
- W0101060204 Urine multi-constituent test strips (manual)
- Device Class
- Class IVD General
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- AT-MF-000000254
Other devices from DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No