Stephanix
FranceFDA applicant, unverified FDA FEI 3006972752
Stephanix is a medical device manufacturer, with 17 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 17
- Registrations
- FDA
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 14
- FDA 510(k) 3
- Device classes
- FDA Class II 17
- FDA recalls
- Identifiers
- FDA FEI 3006972752
- DUNS 381826536
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Stephanix makes
Stephanix manufactures stationary digital fluoroscopic X-ray systems and mobile digital diagnostic X-ray systems designed for general-purpose medical imaging. These devices are intended for intraoperative and procedural imaging, as well as basic diagnostic radiography in clinical settings.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via 510(k) premarket notifications and the FDA’s Unique Device Identification (UDI) system. The devices are listed in the FDA’s regulatory databases.
Catalogue
Search and filter all 17 devicesCompany details
- FDA FEI number
- 3006972752
- DUNS number
- 381826536
- Address
- 10 Rue Jean Moulin, La Ricamarie Auvergne-Rhone-Alpes
FDA recalls
FDA recall records list 1 recall initiated by Stephanix, initiated on 2018-11-02. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 2 Nov 2018 Z-0557-2019 Class II Terminated The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.
Frequently asked questions
How many devices does Stephanix have in the registry?
The registry currently lists 17 devices for Stephanix. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stephanix's devices?
Among its 17 most recently registered devices, Stephanix has devices listed in FDA 510(k) (3 devices) and FDA GUDID (14 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Stephanix's devices fall under?
Among its 17 most recently registered devices, the classes recorded for Stephanix's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Stephanix?
FDA recall records list 1 recall initiated by Stephanix, the most recent initiated on 2 Nov 2018. 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 Stephanix in the registry?
The most recently registered devices listed for Stephanix include STEPHANIX D2RS_B1_NV2, STEPHANIX D2RS, STEPHANIX D2RS_AT_PA and STEPHANIX D2RS_9090_AT_PA.