Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name: FUJIFILM FDA UDI
Generic Name: Endoscopic light source unit, line-powered FDA UDI
Device Name: The BL-7000X Light Source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices FDA UDI
Model / Reference: BL-7000X FDA UDI
Description: The BL-7000X Light Source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410446081 FDA UDI
FDA Product Code: FET FDA UDI
GCJ FDA UDI
MUD FDA UDI
NWB FDA UDI
PEA FDA UDI
NTN FDA UDI
GMDN Term: Endoscopic light source unit, line-powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
870.2700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

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Manufacturing Date

Yes

FDA UDI

Category: Endoscopic light source unit, line-powered

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

Similar devices

Also classified as Endoscopic light source unit, line-powered.

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Endoscope Light Source — Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class I
SL-EL200 — SONOSCAPE MEDICAL CORP. · Class IIa
LED 610 Light source — Erbe Vision GmbH · Class I
SPOTLIGHT — Depuy Spine, Inc. · Class II
SL-ED10 — SONOSCAPE MEDICAL CORP. · Class I
SPOTLIGHT ACCESS SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa

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 56722c6a-d4ad-433c-a7be-0db876a1b9be 35 fields · synced May 30, 2026