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Atip LFS
EUDAMEDFDA UDIClass I (EU MDR)
Ref 7757Model 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
- Atip LFS 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 EUDAMED7757 EUDAMEDAtip LFS 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
- 06970163087757 EUDAMEDFDA UDI
- Basic UDI-DI
- 697016308AoralscanElf7V EUDAMED
- Direct Marketing DI
- 06970163087757 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
Atip LFS 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 d6c5383c-5be6-46a6-8de5-1c71e6770cf4 61 fields · synced Jun 19, 2026
- FDA UDI 3537aa3f-0a51-4691-b6d9-be3725d085b2 33 fields · synced May 30, 2026