Identity
- Trade Name
- BIOX FDA UDI
- Generic Name
- Diagnostic x-ray system generator, portable FDA UDI
- Device Name
- The portable x-ray system, BIOX is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The portable x-ray system, BIOX is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800021800045 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Diagnostic x-ray system generator, portable 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diagnostic x-ray system generator, portable
Biox by Digimed Corporation — 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
- Digimed Corporation
Sources (1)
- FDA UDI 6eaebfbf-54fa-4281-9f3b-1b703fcdb1e4 34 fields · synced Jun 8, 2026