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Capella M5
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1878Model AutoScan-DS-EX Pro(H),A-IS Pro3,OS GOLDY,Capella M5,OS-300
Identity
- Trade Name
- Capella M5 EUDAMEDSHINING 3D® FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, laboratory FDA UDI
- Device Name
- The scanner is used to scan and capture the 3D characteristics of dental models including plaster models and impressions. It can work with the supplied software to export the 3D scan data for CAD/CAM. the scan data can be apply for the orthodontic, restoration and implant. FDA UDI
- Model / Reference
- AutoScan-DS-EX Pro(H),A-IS Pro3,OS GOLDY,Capella M5,OS-300 EUDAMED1878 EUDAMEDCapella M5 FDA UDI
- Description
- The scanner is used to scan and capture the 3D characteristics of dental models including plaster models and impressions. It can work with the supplied software to export the 3D scan data for CAD/CAM. the scan data can be apply for the orthodontic, restoration and implant. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970163081878 EUDAMEDFDA UDI
- Basic UDI-DI
- 697016308EXPro(H)RH EUDAMED
- Direct Marketing DI
- 06970163081878 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental milling system, CAD/CAM, laboratory 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
Capella M5 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 | 697016308EXPro(H)RH | 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 95d423f7-915e-49a2-a2ea-287a9c0edbc5 61 fields · synced Jun 18, 2026
- FDA UDI 1da623de-790a-439c-b5c4-ffe094622741 33 fields · synced May 30, 2026