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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)

Page 6 of 20
DeviceModel / ReferenceRegistriesClassStatus
Fujifilm EG-530NP
FDA UDI
Class IIActive
Fujifilm CA-501FJ/A
FDA UDI
Class IActive
Ust-979-3.5 UST-979-3.5
FDA UDI
Class IIActive
Fujifilm CA-500BU
FDA UDI
Class IActive
FDR D-EVO G43i DR-ID 602 SE A E
FDA UDI
Class IIActive
D-EVOIII C25i DR-ID 1814 SE NON CE E
FDA UDI
Class IIActive
Ust-9146i UST-9146I
FDA UDI
Class IIActive
Fujifilm EC-760S-V/L
FDA UDI
Class IIActive
Fujifilm Ap DR-ID 1280 AP KIT E
FDA UDI
Class IIActive
Slide stopper TEST LATERAL NEEDLE STOPPER TEST E
FDA UDI
Class IIActive
24x30 compression plate (Shift) COMP PLATE 24X30 SMALL HA A E
EUDAMEDFDA UDI
Class IIActive
Fujifilm CA-611
FDA UDI
Class IActive
Fujifilm TR-1108A
FDA UDI
Class IIActive
Fujifilm XL-4450
FDA UDI
Class IIActive
18x24L compression plate (Flex) COMP PLATE 18X24 FLEX HA E
EUDAMEDFDA UDI
Class IIActive
Fujifilm AW-603
FDA UDI
Class IActive
Fujifilm DK2620JI -B20-
FDA UDI
Class IIActive
Fujifilm CA-601
FDA UDI
Class IIActive
Fujifilm PB2020-M
FDA UDI
Class IIActive
Eup-S50a EUP-S50A
FDA UDI
Class IIActive
Fujifilm CA-617
FDA UDI
Class IActive
S21 S21
FDA UDI
Class IIActive
Dr-Id 900mc DR-ID 900 MC W MDR E
FDA UDI
Class IIActive
Fujifilm VP-4440HD
FDA UDI
Class IIActive
D-Evo Ii C24 DR-ID 1213 SE A E
FDA UDI
Class IIActive
Fujifilm WB2212FW2
FDA UDI
Class IActive
Arietta 65 ARIETTA 65
FDA UDI
Class IIActive
18x24L comfort paddle (FS) COMP PLATE 18X24 FS HA E
EUDAMEDFDA UDI
Class IIActive
FDR D-EVO II Access Point DR-ID 1200 AP KIT US E
FDA UDI
Class IIActive
Ust-5410h UST-5410H
FDA UDI
Class IIActive
FDR D-EVO III C43i DR-ID 1812 SE MDR E
FDA UDI
Class IIActive
Fujifilm EB-710P
FDA UDI
Class IIActive
Eup-R54aw-33 EUP-R54AW-33
FDA UDI
Class IIActive
Eviva® spacer NEEDLE HOLDER H EV E
FDA UDI
Class IIActive
Fujifilm DK2618J -B30-
FDA UDI
Class IIActive
Dr-Id 613se DR-ID 613 SE WIRED W E
FDA UDI
Class IIActive
ASPIRE Cristalle Digital Breast Tomosynthesis Option DR 3500 TOMO KIT V2.0 USA E
FDA UDI
Class IIIActive
Dummy Cassette (For Mobile) IR DUMMY CASSETTE FOR MBL E
FDA UDI
Class IIActive
Fujifilm CA-503/A
FDA UDI
Class IActive
Needle guide C-L/C-S (20G) NEEDLE GUIDE C 20G E
FDA UDI
Class IIActive
Supria Supria
FDA UDI
Class IIActive
Fdr Cross DR-XD 3000
FDA UDI
Class IIActive
Ust-Mc11-8731 UST-MC11-8731
FDA UDI
Class IIActive
Mp-2785-G20 MP-2785-G20
FDA UDI
Class IIActive
D-EVOIII G80i DR-ID 1836 SE E
FDA UDI
Class IIActive
Ust-9113p-3.5 UST-9113P-3.5
FDA UDI
Class IIActive
Fujifilm DH-116STL
FDA UDI
Class IIActive
ASPIRE Bellus II MIS-1000
FDA UDI
Class IIActive
Ust-52108 UST-52108
FDA UDI
Class IIActive
Mp-2785-G14 MP-2785-G14
FDA UDI
Class IIActive

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