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NeoScan
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 91012Model 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
- NeoScan™ 1000 Tip L (2pcs) EUDAMEDNeoScan FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- Intraoral Scanner EUDAMEDIntroral scanner L tip FDA UDI
- 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 EUDAMED91012 EUDAMEDTP102N FDA UDI
- Description
- Introral scanner L tip FDA UDI
Identifiers
- Catalog Number
- 91012 FDA UDI
- Primary DI / UDI-DI
- 06973993441058 EUDAMEDFDA UDI
- Basic UDI-DI
- 697399344alliedstar01SL EUDAMED
- Direct Marketing DI
- 06973993441058 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Intraoral optical scanning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Intraoral optical scanning system
NeoScan by Alliedstar Medical Equipment Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intraoral optical scanning system.
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- COMFORT+ — D.D.S., Inc. · Class II
- PANDA SCANNER — Ziyang Freqty Medical Equipment Co., Ltd. · Class II
- INTELLISCAN 3D® Intraoral Scanner — Shining 3D Tech Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alliedstar Medical Equipment Co., Ltd.
Sources (2)
- FDA UDI c74eaf55-bc3f-4ddb-b6fe-523f07f346f3 34 fields · synced Jun 19, 2026
- EUDAMED e37f46b2-8bee-4b7e-ac55-a49ebfcb81e1 61 fields · synced Jun 19, 2026