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Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
FUJIFILM FDA UDI
Generic Name
Flexible video enteroscope FDA UDI
Device Name
EI-580BT is a medical electronic endoscope intended to provide endoscopic images for observation, diagnosis, photographing and endoscopictreatment of esophagus, stomach, small intestine, duodenum, ileocecum, large intestines, sigmoid, and rectum. FDA UDI
Model / Reference
EI-580BT FDA UDI
Description
EI-580BT is a medical electronic endoscope intended to provide endoscopic images for observation, diagnosis, photographing and endoscopictreatment of esophagus, stomach, small intestine, duodenum, ileocecum, large intestines, sigmoid, and rectum. FDA UDI

Identifiers

Primary DI / UDI-DI
04547410384536 FDA UDI
510(k) Number
K183032 FDA UDI
FDA Product Code
FDS FDA UDI
FDF FDA UDI
FDA FDA UDI
GMDN Term
Flexible video enteroscope 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

No

FDA UDI

Category: Flexible video enteroscope

Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video enteroscope.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Corporation

Sources (1)

  • FDA UDI fe06b1b4-9234-4a94-b398-ee1a6d2d1d63 36 fields · synced May 30, 2026