iTero Lumina Scanning Unit
by Align Technology Ltd. EUDAMED
Active
Ref 223169Model iTero Lumina System
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081606302LMNSYS9L | Date18 Jun 2024 | 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- Withdrawn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
- iTero Lumina System
- Model / Reference
- iTero Lumina System, 223169
- Primary DI / UDI-DI
- 00816063022961
- Basic UDI-DI
- 081606302LMNSYS9L
- EMDN Code
- Z110601 Laser imaging scanner
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- IL-MF-000000745
- Authorised representative
- Align Technology B.V. NL-AR-000000061
Other devices from Align Technology Ltd.
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