Identity
- Trade Name
- MetiSmile-MR EUDAMEDSHINING 3D® FDA UDI
- Generic Name
- Jaw physiology evaluation system FDA UDI
- Device Name
- The product uses optical scanning method to collect facial 3D data and jaw movement tracking data to provide 3D digital models for facial and oral CAD design. FDA UDI
- Model / Reference
- MetiSmile EUDAMED4213 EUDAMEDMetiSmile-MR FDA UDI
- Description
- The product uses optical scanning method to collect facial 3D data and jaw movement tracking data to provide 3D digital models for facial and oral CAD design. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970163084213 EUDAMEDFDA UDI
- Basic UDI-DI
- 697016308MetiSmilePF EUDAMED
- Direct Marketing DI
- 06970163084213 EUDAMED
- FDA Product Code
- NFS FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Jaw physiology evaluation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.2060 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
MetiSmile-MR 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 | 697016308MetiSmilePF | 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 6c8d2de4-2239-49e1-9da0-1262171f6d64 61 fields · synced Jun 19, 2026
- FDA UDI 79e892e9-227c-42e5-a8e6-10eb782c420d 33 fields · synced May 30, 2026