Identity
- Trade Name
- SuniRay2 FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- The SuniRay2 Digital Radiography System is a semiconductor imaging device intended to acquire real‐time intra‐oral dental radiography images in combination with a dedicated dental Imaging Software. The Digital Radiography System is available either with a #2 or #1 sensor size. It is intended to be used by dentists to diagnose dental diseases. FDA UDI
- Model / Reference
- Sensor size #2 FDA UDI
- Description
- The SuniRay2 Digital Radiography System is a semiconductor imaging device intended to acquire real‐time intra‐oral dental radiography images in combination with a dedicated dental Imaging Software. The Digital Radiography System is available either with a #2 or #1 sensor size. It is intended to be used by dentists to diagnose dental diseases. FDA UDI
Identifiers
- Catalog Number
- 400-1227-B FDA UDI
- Primary DI / UDI-DI
- 00851067007002 FDA UDI
- FDA Product Code
- MUH FDA UDI
- GMDN Term
- Dental digital imaging sensor, intraoral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental digital imaging sensor, intraoral
SuniRay2 by Suni Medical Imaging, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Suni Medical Imaging, Inc.
Sources (1)
- FDA UDI 94f6c12c-1f38-4b0b-aaeb-766fe499f755 36 fields · synced May 30, 2026