Azmed
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000014277 FEI 3026753394
Azmed is a medical device manufacturer based in France, with 9 devices listed in EUDAMED, FDA 510(k) and FDA GUDID (FDA Class II; EU Class IIa) as of 15 Nov 2026.
- Devices
- 9
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 3
- FDA 510(k) 3
- FDA GUDID 3
- Device classes
- FDA Class II 6
- EU Class IIa 3
- Top EMDN categories
- Identifiers
- EUDAMED SRN FR-MF-000014277
- FDA FEI 3026753394
- DUNS 271425256
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
What Azmed makes
AZmed makes the Rayscan and Rayvolve product lines, including specific models such as Rayvolve PTX-PE and Rayvolve LN. These are AI-powered tools designed for use in medical imaging.
The devices are classified as Class II and Class IIa and are listed in the Eudamed and FDA 510(k) registries. The company is based in France.
Catalogue
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
Rayvolve Ref Rayvolve - VM + Cloud (version 8)
Regimes: CE MDR Registry: EUDAMEDRayvolve AZchest Ref K261378
Regimes: 510(k) Registry: 510(k)Rayvolve Ref Rayvolve - On-premise (Version 5)
Regimes: CE MDR Registry: EUDAMEDRayvolve PTX-PE Ref K243808
Regimes: CE MDR 510(k) Registry: 510(k)Rayvolve LN Ref K243831
Regimes: 510(k) Registry: 510(k)Rayvolve Ref Rayvolve- On premise (Version 2)
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- FR-MF-000014277
- FDA FEI number
- 3026753394
- DUNS number
- 271425256
- EU VAT number
- FR41841673601
- EUDAMED status
- Active
- EUDAMED registered name
- AZmed
- EUDAMED abbreviated name
- AZmed
- Registered address
- 10, Rue d'Uzès, 75002, Paris, France
- Website
- azmed.co/
- linkedin.com/company/azmed-co
- Julien@azmed.co
- Phone
- + 33 6 49 69 78 59
- PRRC contact
- Shanni Zeitoun
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 13 Apr 2031
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 731678 Active
Quality management system EU MDR
- Issued
- 8 Apr 2026
- Expires
- 13 Apr 2031
- Valid from
- 14 Apr 2026
FDA establishments
- Azmed Sas FR
From the company website
Founded in 2018, AZmed is a European MedTech company developing AI solutions for medical imaging. Its Rayvolve AI Suite includes FDA-cleared and CE-marked tools, while its Rayscan line is CE-marked. Used by more than 2,500 healthcare facilities worldwide, AZmed's solutions improve diagnostic consistency and operational efficiency in medical imaging.
Frequently asked questions
How many devices does AZMED have in the registry?
The registry currently lists 9 devices for AZMED. Devices recorded under merged duplicate company entries are counted once.
Which registries list AZMED's devices?
Among its 9 most recently registered devices, AZMED has devices listed in EUDAMED (3 devices), FDA 510(k) (3 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do AZMED's devices fall under?
Among its 9 most recently registered devices, the classes recorded for AZMED's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for AZMED?
EUDAMED lists 1 certificate for AZMED (quality management system) under MDR. The most recent was issued on 8 Apr 2026.
What are the newest devices from AZMED in the registry?
The most recently registered devices listed for AZMED include Rayvolve 7, Rayvolve, Rayvolve AZchest and Rayvolve PTX-PE.
Which FDA establishments are linked to AZMED?
1 FDA establishment is linked to AZMED in the registry; they are listed on the company page.