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Aoralscan Elf (R)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5883Model CS-A48-A，CS-A48-B，CS-A48-C，CS-A48-D，CS-A48-E，CS-A48-F，CS-A48-G，CS-A48-H，CS-A48-I，CS-A48-J，CS-A48-K,CS-A48-L,CS-A43-A,CS-A35-A,CS-A35-B，CS-A48M2-A
Identity
- Trade Name
- Aoralscan Elf (R) EUDAMEDSHINING 3D® FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- Scanbody EUDAMEDThis is an intraoral scanner that works with the supplied software programs. By performing scanning directly and digitally acquiring and saving the 2D/3D color images of teeth, gingiva and oral mucosa, the scanner is available for patients with needs of orthodontic, implant, and restoration. FDA UDI
- Model / Reference
- CS-A48-A，CS-A48-B，CS-A48-C，CS-A48-D，CS-A48-E，CS-A48-F，CS-A48-G，CS-A48-H，CS-A48-I，CS-A48-J，CS-A48-K,CS-A48-L,CS-A43-A,CS-A35-A,CS-A35-B，CS-A48M2-A EUDAMED5883 EUDAMEDAoralscan Elf (R) FDA UDI
- Description
- This is an intraoral scanner that works with the supplied software programs. By performing scanning directly and digitally acquiring and saving the 2D/3D color images of teeth, gingiva and oral mucosa, the scanner is available for patients with needs of orthodontic, implant, and restoration. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970163085883 EUDAMEDFDA UDI
- Basic UDI-DI
- 697016308AoralscanElf7V EUDAMED
- Direct Marketing DI
- 06970163085883 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
Yes
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 Elf (R) 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 | 697016308AoralscanElf7V | 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 bda307ff-bdc0-4b81-930f-0d462d971c5f 61 fields · synced Jun 18, 2026
- FDA UDI 833f99c1-bce1-43e3-8832-2f91abc8b3db 33 fields · synced May 30, 2026