Hiris TSI Box
by A.T.S. Applicazione Tecnologie Speciali s.r.l. EUDAMED
Active
Ref 11 01 100
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805518667TSIBOXSN | Date23 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Hiris TSI Box
- Model / Reference
- 11 01 100
- Primary DI / UDI-DI
- 08055186671409
- Basic UDI-DI
- 805518667TSIBOXSN
- Direct Marketing DI
- 08055186671409
- EMDN Code
- Z11039099 Various radiodiagnostic and interventional instruments – other
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000010734
Other devices from A.T.S. Applicazione Tecnologie Speciali s.r.l.
See all devices from A.T.S. Applicazione Tecnologie Speciali s.r.l. →
Properties
Other properties (13)
- Sterile: No
- 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