VitaDX International
Active in EUDAMEDFrancefrom SRN EUDAMED SRN FR-MF-000001855
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What VitaDX International makes
VitaDX International manufactures the Visiocyt Bladder, a diagnostic device designed for cytological analysis of bladder samples. This product is intended for use in the detection and examination of cellular abnormalities in urine specimens, aiding in the assessment of bladder health and potential pathologies.
The company’s portfolio is classified under Class C medical devices in the European Union, and its products are registered in the EUDAMED database. VitaDX International operates from France, adhering to EU regulatory requirements for medical device compliance.
Catalogue
- Regimes: CE IVDR Registry: EUDAMED
Visiocyt Bladder Ref Visocyt Bladder
Regimes: CE IVDR Registry: EUDAMED
Company details
- EUDAMED SRN
- FR-MF-000001855
- EU VAT number
- FR38811141977
- EUDAMED status
- Active
- EUDAMED registered name
- VitaDX International
- EUDAMED abbreviated name
- VitaDX
- Registered address
- 74F, rue de Paris, 35000, Rennes, France
- Website
- www.vitadx.com/
- linkedin.com/company/vitadx
- [email protected]
- Phone
- +33143214455
- PRRC contact
- Raphaël Moustié
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 2 Oct 2028
BSI Group The Netherlands B.V. 2797 1 certificate
- IVDR 750182 Active
Quality management system EU IVDR
- Issued
- 3 Oct 2023
- Expires
- 2 Oct 2028
Frequently asked questions
How many devices does VitaDX International have in the registry?
The registry currently lists 2 devices for VitaDX International. Devices recorded under merged duplicate company entries are counted once.
Which registries list VitaDX International's devices?
Among its 2 most recently registered devices, VitaDX International has devices listed in EUDAMED (2 devices).
What risk classes do VitaDX International's devices fall under?
Among its 2 most recently registered devices, the classes recorded for VitaDX International's devices are IVDR Class C. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for VitaDX International?
EUDAMED lists 1 certificate for VitaDX International (quality management system) under IVDR. 1 is recorded with the status issued. The most recent was issued on 3 Oct 2023.
What are the newest devices from VitaDX International in the registry?
The most recently registered devices listed for VitaDX International include Visiocyt Bladder.