Intraoral Scanner
by Alliedstar Medical Equipment Co., Ltd. 19 variants
Part of a family of 89 devices: see the family page
Ref 6583704Model AS 100, AS 200E, AS 260, AS 260a, S300W, ST 200E, ST 300E, NeoScan 1000, NeoScan 2000, Owandy ios, Owandy ios Wireless, DI-1
Intraoral Scanner (6583704) is a Class I device made by Alliedstar Medical Equipment Co., Ltd., registered in EUDAMED on 12 Jun 2025 (Basic UDI-DI 697399344alliedstar01SL), active as of 7 Nov 2026.
Active
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697399344alliedstar01SL 06973993442901 | Date12 Jun 2025 | StatusActive |
Official records
- EUDAMED public site 697399344alliedstar01SL
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- Withdrawn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/MDR Active
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, 6583704
- Primary DI / UDI-DI
- 06973993442901
- Basic UDI-DI
- 697399344alliedstar01SL
- EMDN code
- Q010207 Dental impression devices for prosthetic dentistry
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000008845
- Authorised representative
- Etkon GmbH DE-AR-000009335
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