AUTOANALYZER MOD. MIURA ONE (15 Smp Pos) p/n 10750-02-A
by I.S.E. - Societa' a Responsabilita' Limitata - Sistemi Intelligenti Elettronici
Ref I3310001209
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number803380351BCAAMIURAONE014X 08033803510423 | Date13 Jul 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Autoanalyzer Mod. Miura One
- Model / Reference
- I3310001209
- Primary DI / UDI-DI
- 08033803510423
- Basic UDI-DI
- 803380351BCAAMIURAONE014X
- Direct Marketing DI
- 08033803510423
- EMDN Code
- W0201030101 MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
- Device Class
- Class A
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000028898
Other devices from I.S.E. - Societa' a Responsabilita' Limitata - Sistemi Intelligenti Elettronici
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No