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: This device provides illumination to an endoscope and supplies air and water to body cavities via the endoscope, and is intended to provide images captured by the endoscope for endoscopic procedure. FDA UDI
Model / Reference: BL-7000 FDA UDI
Description: This device provides illumination to an endoscope and supplies air and water to body cavities via the endoscope, and is intended to provide images captured by the endoscope for endoscopic procedure. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410337730 FDA UDI
510(k) Number: K192918 FDA UDI
FDA Product Code: NTN FDA UDI
FET FDA UDI
GCJ FDA UDI
NWB FDA UDI
PEA 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
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

FDA UDI

Expiration Date

FDA UDI

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.

Light Sources, Fiberoptic — STEMA Medizintechnik GmbH · Class I
SPOTLIGHT ACCESS SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
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

Cleared under the same submission

K192918 also covers:

FUJIFILM — FUJIFILM Corporation

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 b84058cd-5d01-49f8-af2d-08b26a33c1d1 36 fields · synced May 30, 2026