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Aoralscan Elite Wireless
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8426Model Aoralscan Elite Wireless
Identity
- Trade Name
- Aoralscan Elite Wireless EUDAMEDSHINING 3D® FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- Intraoral Scanner EUDAMEDThe intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing. FDA UDI
- Model / Reference
- Aoralscan Elite Wireless EUDAMEDFDA UDI8426 EUDAMED
- Description
- The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970163088426 EUDAMEDFDA UDI
- Basic UDI-DI
- 697016308AoralscanEWFM EUDAMED
- Direct Marketing DI
- 06970163088426 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental milling system, CAD/CAM, chairside FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Aoralscan Elite Wireless by Shining 3D Tech Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697016308AoralscanEWFM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shining 3D Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008402
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED b8d6b481-8e8d-40cf-b6d1-c5d0456d1e4d 61 fields · synced Jul 26, 2026
- FDA UDI 385c2a05-ef84-4a81-83cf-047fb3b9b3aa 33 fields · synced May 30, 2026