Canon Inc.
Active in EUDAMEDJapanfrom SRN EUDAMED FDA SRN JP-MF-000013254 FEI 1000181430
Canon Inc. is a medical device manufacturer based in Japan, with 375 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class IIa and I) and 2 FDA recalls as of 13 Nov 2026.
- Devices
- 375
- Registrations
- EUDAMEDFDA
- FDA recalls
- 2
Registry facts
- Registries
- FDA GUDID 303
- EUDAMED 168
- FDA 510(k) 33
- Device classes
- FDA Class II 323
- EU Class IIa 40
- EU Class I 7
- FDA Class I 3
- EU Class IIb 2
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Canon Medical Components Europe B.V. authorised representative
- Canon Medical Systems Europe B.V. authorised representative
- Identifiers
- EUDAMED SRN JP-MF-000013254
- FDA FEI 1000181430
- DUNS 690549662
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Canon Medical Components Europe B.V.NL
- Authorised rep.
- Canon Medical Systems Europe B.V.NL
What Canon Inc. makes
Canon Inc. makes a range of medical devices, including computed radiography digital imaging scanners, stationary basic diagnostic x-ray systems, ophthalmic fundus cameras, and stationary general-purpose fluoroscopic x-ray systems. They also produce automated ophthalmic refractometers and other ophthalmic devices such as full auto ref-keratometers and full auto tonometers.
The company's portfolio is regulated under various device classes, including Class I, Class II, and Class IIa, and is listed in registries such as Eudamed, FDA 510(k), and FDA UDI. Canon Inc. is based in Japan.
Catalogue
Search and filter all 375 devicesShowing 1-50 of 375
Company details
- EUDAMED SRN
- JP-MF-000013254
- FDA FEI number
- 1000181430
- DUNS number
- 690549662
- EUDAMED status
- Active
- EUDAMED registered name
- Canon Inc.
- Registered address
- 30-2, SHIMOMARUKO,3-CHOME, 146-8501, OHTA-KU,TOKYO, Japan
- Phone
- 800-970-7227
- PRRC contact
- Junichiro Araoka
FDA recalls
FDA recall records list 2 recalls initiated by CANON INC., the earliest on 2010-11-01 and the most recent on 2012-12-05. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination, packaging and electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 5 Dec 2012 Z-1404-2013 Class II Terminated Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability.
2010
- 1 Nov 2010 Z-2265-2012 Class II Terminated Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
Frequently asked questions
How many devices does CANON INC. have in the registry?
The registry currently lists 375 devices for CANON INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list CANON INC.'s devices?
Among its 50 most recently registered devices, CANON INC. has devices listed in EUDAMED (29 devices) and FDA GUDID (25 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do CANON INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for CANON INC.'s devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for CANON INC.?
FDA recall records list 2 recalls initiated by CANON INC., the most recent initiated on 5 Dec 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from CANON INC. in the registry?
The most recently registered devices listed for CANON INC. include Transducer for Diagnostic Ultrasound System, Biopsy Adapter, Computed Tomography Scanning System and Diagnostic Ultrasound System.