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Fujifilm Corporaton

Japan·JP-MF-000010401

Last updated May 23, 2026

What Fujifilm Corporaton makes

The company manufactures medical imaging and endoscopic devices, including video laparoscopes, endoscopes with attachments like over-tubes and balloons, and image processing units for cardiac and general surgical applications. Their portfolio also includes processor systems and light sources for medical imaging workflows, as well as specialized 3D cardiac tools for diagnostic procedures.

These devices are classified as Class II under FDA regulations and are listed in the 510(k) clearance registry. The company operates with a US-based presence, adhering to applicable regulatory requirements for these medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Fujifilm Corporation manufacture?

Fujifilm Corporation specializes in medical imaging and endoscopic devices. This includes video laparoscopes like the EL-R740M30, endoscopes (such as the EI-740D/S and EB-710P) along with accessories like over-tubes, balloons, and tube kits. Their portfolio also covers image processing units (e.g., Synapse 3D Cardiac Tools), processor systems (VP-7000), and light sources (BL-7000X) designed for surgical and diagnostic workflows.

Where is Fujifilm Corporation based, and how does this affect its regulatory compliance?

Fujifilm Corporation has a US-based presence, which means its devices must comply with FDA regulations. The company’s products are subject to FDA oversight, including classification and clearance processes, ensuring they meet safety and performance standards for the US market.

How are Fujifilm Corporation’s medical devices classified under FDA regulations?

Fujifilm Corporation’s devices fall under Class II classification by the FDA. This classification applies to moderate-risk medical devices that require special controls beyond general controls to ensure their safety and effectiveness. Class II devices typically require a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device.

Which regulatory registries list Fujifilm Corporation’s medical devices?

Fujifilm Corporation’s medical devices are listed in the FDA’s 510(k) clearance registry. This registry documents premarket submissions for Class II devices, showing that each product has undergone evaluation to confirm compliance with FDA requirements before commercial distribution.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Japan
Address
26-30, Nishiazabu 2-Chome, Minato-ku, Tokyo, Japan
Website
fujifilm.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
—
PRRC Contact
Naotake Mitsumori
EUDAMED SRN
JP-MF-000010401
FDA FEI Number
—
DUNS Number
—

Catalogue (993)

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DeviceModel / ReferenceRegistriesClassStatus
Ust-9120 UST-9120
FDA UDI
Class IIActive
Vc34a VC34A
FDA UDI
Class IIActive
Fujifilm WB11002FW2
FDA UDI
Class IActive
Ust-981-5 UST-981-5
FDA UDI
Class IIActive
Fujifilm EB-580T
FDA UDI
Class IIActive
Fujifilm DH-17EN2
FDA UDI
Class IIActive
Vc34 VC34
FDA UDI
Class IIActive
C42t C42T
FDA UDI
Class IIActive
Needle holder E NEEDLE HOLDER EN E
FDA UDI
Class IIActive
Mp-2781 MP-2781
FDA UDI
Class IIActive
D-Evoiii G43 DR-ID 1802 SE E
FDA UDI
Class IIActive
Vehicle-monted option DR 3500 MBL KIT HA USA E
FDA UDI
Class IIActive
Fujifilm SB-601
FDA UDI
Class IActive
FCR ClearView CS Plus CR-IR 363
FDA UDI
Class IIActive
Fujifilm SB-602
FDA UDI
Class IIActive
Dr-Id 1201se DR-ID 1201 SE W E
FDA UDI
Class IIActive
L46k L46K
FDA UDI
Class IIActive
Ust-5534t-7.5 UST-5534T-7.5
FDA UDI
Class IIActive
Ust-9132i UST-9132I
FDA UDI
Class IIActive
Mp-2785-G18 MP-2785-G18
FDA UDI
Class IIActive
Ust-533 UST-533
FDA UDI
Class IIActive
Fujifilm FV-003
FDA UDI
Class IIActive
24x30H comfort paddle (FS) COMP PLATE 24X30 FS HA E
EUDAMEDFDA UDI
Class IIActive
Fujifilm LT-100
FDA UDI
Class IActive
Fujifilm DH-29CR
FDA UDI
Class IIActive
Magnification table MAG TABLE HA E
FDA UDI
Class IIActive
Ust-536 UST-536
FDA UDI
Class IIActive
FDR D-EVO G35s DR-ID 601 SE WIRED A E
FDA UDI
Class IIActive
Dr-Id 1305se DR-ID 1305 SE E
FDA UDI
Class IIActive
Ust-5045p-3.5 UST-5045P-3.5
FDA UDI
Class IIActive
Fujifilm EC-760S-A/L
FDA UDI
Class IIActive
Flat panel sensor holder DR-XD 3000 HOLDER2530 E
FDA UDI
Class IIActive
Fujifilm EB-530T
FDA UDI
Class IIActive
Ust-9133 UST-9133
FDA UDI
Class IIActive
Cr-Ir 392 CR-IR 392
FDA UDI
Class IIActive
Needle holder C NEEDLE HOLDER C E
FDA UDI
Class IIActive
Ust-52119s UST-52119S
FDA UDI
Class IIActive
Ust-9132t UST-9132T
FDA UDI
Class IIActive
FDR D-EVO III G80i DR-ID 1836 SE MDR E
FDA UDI
Class IIActive
Dr-Id 1211se DR-ID 1211 SE W E
FDA UDI
Class IIActive
Fujifilm DK2623JI -N15-
FDA UDI
Class IIActive
Eup-B715 EUP-B715
FDA UDI
Class IIActive
FDR D-EVO plus C43i DR-ID 612 SE E
FDA UDI
Class IIActive
D-Evo Ii G35 DR-ID 1201 SE A E
FDA UDI
Class IIActive
Eup-Es52m EUP-ES52M
FDA UDI
Class IIActive
Ust-9104-5 UST-9104-5
FDA UDI
Class IIActive
Mp-2785-G23 MP-2785-G23
FDA UDI
Class IIActive
FDR SE Console DR-ID330CL
EUDAMEDFDA UDI
Class IIActive
Fujifilm PB2020-M2
FDA UDI
Class IIActive
Fujifilm TR-1507A
FDA UDI
Class IIActive

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