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Intraoral Scanner
EUDAMEDClass I (EU MDR)
Ref 6583360Model AS 100, AS 200E, AS 260, AS 260a, S300W, ST 200E, ST 300E, NeoScan 1000, NeoScan 2000, Owandy ios, Owandy ios Wireless, DI-1
Identity
- Trade Name
- Intraoral Scanner EUDAMED
- Device Name
- Intraoral Scanner EUDAMED
- 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 EUDAMED6583360 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973993442130 EUDAMED
- Basic UDI-DI
- 697399344alliedstar01SL EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Intraoral Scanner by Alliedstar Medical Equipment Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697399344alliedstar01SL | Class I | Active |
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Manufacturer
- Manufacturer
- Alliedstar Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000008845
- Authorised Representative
- Etkon GmbH DE-AR-000009335
Sources (1)
- EUDAMED 5d66b447-b850-47cb-9181-df06aa9da2fc 61 fields · synced Jun 19, 2026