← Back to manufacturers

Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

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 3 of 20
DeviceModel / ReferenceRegistriesClassStatus
FDR D-EVO III G43i DR-ID 1832 SE MDR E
FDA UDI
Class IIActive
Slide stopper M LATERAL NEEDLE STOPPER M E
FDA UDI
Class IIActive
Fujifilm EC-860P/M
FDA UDI
Class IIActive
Chest wall pad CHEST WALL PAD E
FDA UDI
Class IIActive
Fuji Imaging Plate IP-6 ST 18X24CM 1 E
FDA UDI
Class IActive
Ust-9104-5 UST-9104-5
FDA UDI
Class IIActive
Fujifilm EG-600WR
FDA UDI
Class IIActive
Fuji Imaging Plate IP-6 ST 24X30CM 1 E
FDA UDI
Class IActive
Fujifilm CA-610
FDA UDI
Class IActive
Biopsy compression plate COMP PLATE BIOPSY HA E
FDA UDI
Class IIActive
Cradle DR613 STAND E
FDA UDI
Class IIActive
Magazine S DPX LITE MAGAZINE S : E
FDA UDI
Class IIActive
Fujifilm SU-1 FV652A
FDA UDI
Class IIActive
Docking stand DR-ID 1200 DS E
FDA UDI
Class IIActive
Eup-Cc531 EUP-CC531
FDA UDI
Class IIActive
D-EVOIII G35i DR-ID 1831 SE NON CE E
FDA UDI
Class IIActive
Dr-Id 1213se DR-ID 1213 SE W SDK E
FDA UDI
Class IIActive
Ust-9124 UST-9124
FDA UDI
Class IIActive
Ust-5419 UST-5419
FDA UDI
Class IIActive
24x30 Compression plate (Low) COMP PLATE 24X30 LOW HA A E
EUDAMEDFDA UDI
Class IIActive
Mp-2448 MP-2448
FDA UDI
Class IIActive
Ust-670p-5 UST-670P-5
FDA UDI
Class IIActive
Fujifilm TS-12140
FDA UDI
Class IIActive
AWS-c CR-IR363AWS
FDA UDI
Class IIActive
Fujifilm DH-096ST
FDA UDI
Class IIActive
Fujifilm EG-760Z
FDA UDI
Class IIActive
Monitor cart DR-XD 3000MX
FDA UDI
Class IIActive
Arietta 70 ARIETTA 70
FDA UDI
Class IIActive
Dr-Id 1283se DR-ID 1283 SE E
FDA UDI
Class IIActive
Fujifilm EC-860P/L
FDA UDI
Class IIActive
Dr-Id 601se DR-ID 601 SE A W E
FDA UDI
Class IIActive
Eup-S72 EUP-S72
FDA UDI
Class IIActive
Dr-Id900cl DR-ID900CL
FDA UDI
Class IIActive
Grid (17x17) DR-XD 3000 GRID4343 E
FDA UDI
Class IIActive
S22 S22
FDA UDI
Class IIActive
Dr-Id 1201se DR-ID 1201 SE W SDK E
FDA UDI
Class IIActive
Fcr Prima T2 CR-IR 392
FDA UDI
Class IIActive
Fujifilm TS-13101
FDA UDI
Class IIActive
Fujifilm BS-102
FDA UDI
Class IIActive
Eup-Vv731 EUP-VV731
FDA UDI
Class IIActive
FDR D-EVO plus C35s DR-ID 611 SE WIRED E
FDA UDI
Class IIActive
Fujifilm LMP-001
FDA UDI
Class IActive
18x24 Compression plate (Low) COMP PLATE 18X24 LOW HA A E
EUDAMEDFDA UDI
Class IIActive
Ba-001 BA-001
FDA UDI
Class IIActive
Ust-5710-7.5 UST-5710-7.5
FDA UDI
Class IIActive
Ust-568 UST-568
FDA UDI
Class IIActive
D-EVOIII C43i DR-ID 1812 SE E
FDA UDI
Class IIActive
C41 C41
FDA UDI
Class IIActive
Fuji Medical Dry Film DI-AL 35X43 100 +
FDA UDI
Class IIActive
Li-polymer BATTERY CHARGER DR1280 SE BATTERY CHARGER E
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.