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Sign in to claim this brandFujifilm 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
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Naotake Mitsumori
- EUDAMED SRN
- JP-MF-000010401
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (993)
Page 5 of 20| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| L31kp | L31KP | FDA UDI | Class II | Active |
| Ust-9145 | UST-9145 | FDA UDI | Class II | Active |
| Fujifilm | EG-740UT | FDA UDI | Class II | Active |
| Dr-Id 600mc | DR-ID 601 MC-WITHOUT SOFT E | FDA UDI | Class II | Active |
| Fujifilm | EB-530P | FDA UDI | Class II | Active |
| 18x24 compression plate (Small) | COMP PLATE 18X24 SMALL HA A E | FDA UDI | Class II | Active |
| Fujifilm | ES-530WE | FDA UDI | Class II | Active |
| Fcr Prima T2 | CR-IR 392 | FDA UDI | Class II | Active |
| Needle guide C-L/C-S (14G) | NEEDLE GUIDE C 14G E | FDA UDI | Class II | Active |
| Fujifilm | EG-530D | FDA UDI | Class II | Active |
| Fujifilm | DK2618J -N15- | FDA UDI | Class II | Active |
| FDR D-EVOII Battery Charger | DR1200 SE BATTERY CHARGER B E | FDA UDI | Class II | Active |
| Fujifilm | CB-01B | FDA UDI | Class I | Active |
| Fujifilm | EG-530CT | FDA UDI | Class II | Active |
| Fujifilm | DK2618J -B25- | FDA UDI | Class II | Active |
| Mp-2458 | MP-2458 | FDA UDI | Class II | Active |
| S31kp | S31KP | FDA UDI | Class II | Active |
| Mp-2794-G16 | MP-2794-G16 | FDA UDI | Class II | Active |
| Fujifilm | CA-614 | FDA UDI | Class I | Active |
| DRYPIX Plus | DRYPIX 4000 | FDA UDI | Class II | Active |
| Fujifilm | EB-530S | FDA UDI | Class II | Active |
| Fujifilm | SB-500/G | FDA UDI | Class I | Active |
| Ust-5296 | UST-5296 | FDA UDI | Class II | Active |
| Transportation carriage | DR-XD 1000 CARRY CART E | FDA UDI | Class II | Active |
| Fujifilm | EG-600WR v2 | FDA UDI | Class II | Active |
| D-Evo Ii C43 | DR-ID 1212 SE A E | FDA UDI | Class II | Active |
| Fujifilm | DK2620JI -B30- | FDA UDI | Class II | Active |
| Aloka Lisendo 880 | ALOKA LISENDO 880 | FDA UDI | Class II | Active |
| ARIETTA Precision | ARIETTA Precision | FDA UDI | Class II | Active |
| C42k | C42K | FDA UDI | Class II | Active |
| Dr-Id 911se | DR-ID 911 SE W E | FDA UDI | Class II | Active |
| Fujifilm | CP-1TB | FDA UDI | Class I | Active |
| Eup-L75 | EUP-L75 | FDA UDI | Class II | Active |
| Li-ion Battery | DR601 SE BATTERY E | FDA UDI | Class II | Active |
| Arietta 50 | ARIETTA 50 | FDA UDI | Class II | Active |
| Dr-Id 600mc | DR-ID 600 MC E | FDA UDI | Class II | Active |
| Oasis | OASIS | FDA UDI | Class II | Active |
| Fdr Es G35 | DR-ID 1271 SE E | FDA UDI | Class II | Active |
| Dr-Id 1212se | DR-ID 1212 SE W SDK E | FDA UDI | Class II | Active |
| Round spot compression plate | COMP PLATE ROUND SPOT HA E | EUDAMEDFDA UDI | Class II | Active |
| SE storage case | DR602 SE CASE E | FDA UDI | Class II | Active |
| SE communication cable | DR-ID 1200 AP-SE CBL E | FDA UDI | Class II | Active |
| Fujifilm | DH-38CZ | FDA UDI | Class II | Active |
| Ust-52128 | UST-52128 | FDA UDI | Class II | Active |
| Fujifilm | EB-580S | FDA UDI | Class II | Active |
| Fdr-2000bpy | POSITIONER KIT BPY-L HA USA E | FDA UDI | Class II | Active |
| Needle holder V | NEEDLE HOLDER V E | FDA UDI | Class II | Active |
| FDR D-EVO plus C24s | DR-ID 613 SE WIRED E | FDA UDI | Class II | Active |
| Eup-C532 | EUP-C532 | FDA UDI | Class II | Active |
| Ust-9130 | UST-9130 | FDA UDI | Class II | Active |
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