Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Flexible video gastroduodenoscope FDA UDI
- Device Name
- The device is intended for the visualization of upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally. FDA UDI
- Model / Reference
- EG-530NP FDA UDI
- Description
- The device is intended for the visualization of upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410331035 FDA UDI
- FDA Product Code
- FDS FDA UDI
- GMDN Term
- Flexible video 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
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
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 video gastroduodenoscope
Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video gastroduodenoscope.
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- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- GASTROINTESTINAL VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
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 bfcc8dd5-b90f-45fa-a4be-885e5ac9d0bc 35 fields · synced May 30, 2026