Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Flexible ultrasound gastroduodenoscope FDA UDI
- Device Name
- Fujinon/Fujifilm Ultrasonic Endoscopes, EG-530UR2 is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujifilm ultrasonic processor. This product is not intended for use on children and infants. FDA UDI
- Model / Reference
- EG-530UR2 FDA UDI
- Description
- Fujinon/Fujifilm Ultrasonic Endoscopes, EG-530UR2 is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujifilm ultrasonic processor. This product is not intended for use on children and infants. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410330205 FDA UDI
- FDA Product Code
- FDS FDA UDI
- GMDN Term
- Flexible ultrasound gastroduodenoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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: Flexible ultrasound gastroduodenoscope
Fujifilm by FUJIFILM 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
- FUJIFILM Corporation
Sources (1)
- FDA UDI df7d12a6-c92e-4e1b-9487-0dbc5965bb73 35 fields · synced May 31, 2026