Apelem
Country not established
Apelem is a medical device manufacturer, with 21 devices listed in EUDAMED and FDA GUDID (EU Class IIb; FDA Class II) as of 12 Nov 2026.
- Devices
- 21
Registry facts
- Registries
- EUDAMED 14
- FDA GUDID 7
- Device classes
- EU Class IIb 14
- FDA Class II 7
- Top EMDN categories
- Sites and related companies
- Apelem France
- Identifiers
- DUNS 268596533
What Apelem makes
The company manufactures powered tabletop systems designed for basic diagnostic X-ray imaging, used in medical settings for capturing radiographic images of patients.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database.
Catalogue
Search and filter all 21 devicesCompany details
- DUNS number
- 268596533
Sites
- Apelem FRFEI 3000255482 14 devices
Frequently asked questions
How many devices does APELEM have in the registry?
The registry currently lists 21 devices for APELEM. Devices recorded under merged duplicate company entries are counted once.
Which registries list APELEM's devices?
Among its 21 most recently registered devices, APELEM has devices listed in EUDAMED (14 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do APELEM's devices fall under?
Among its 21 most recently registered devices, the classes recorded for APELEM's devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from APELEM in the registry?
The most recently registered devices listed for APELEM include MEDIX90 (compact version), Mobile X-ray System, ONYX and STRATOS.