RMA, Wheel Stand Replacement
by Align Technology (Sichuan) Medical Equipment Co., Ltd. EUDAMED
Active
Ref 223153Model iTero Lumina
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697536203LMNSYSUZ | Date27 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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 Intraoral Scanner
- Model / Reference
- iTero Lumina, 223153
- Primary DI / UDI-DI
- 06975362030849
- Basic UDI-DI
- 697536203LMNSYSUZ
- EMDN Code
- Q010207 Dental impression devices for prosthetic dentistry
- Device Class
- Class I
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000024868
- Authorised representative
- Align Technology B.V. NL-AR-000000061
Other devices from Align Technology (Sichuan) Medical Equipment Co., Ltd.
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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