Intraoral Scanner
by Alliedstar Medical Equipment Co., Ltd. EUDAMED
Active
Ref 6583439Model AS 100, AS 200E, AS 260, AS 260a, S300W, ST 200E, ST 300E, NeoScan 1000, NeoScan 2000, Owandy ios, Owandy ios Wireless, DI-1
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697399344alliedstar01SL | Date12 Jun 2025 | 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- Withdrawn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
- Model / Reference
- AS 100, AS 200E, AS 260, AS 260a, S300W, ST 200E, ST 300E, NeoScan 1000, NeoScan 2000, Owandy ios, Owandy ios Wireless, DI-1, 6583439
- Primary DI / UDI-DI
- 06973993442420
- Basic UDI-DI
- 697399344alliedstar01SL
- EMDN Code
- Q010207 Dental impression devices for prosthetic dentistry
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000008845
- Authorised representative
- Etkon GmbH DE-AR-000009335
Other devices from Alliedstar Medical Equipment Co., Ltd.
See all devices from Alliedstar Medical Equipment Co., 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