Artiria Medical SA
Active in EUDAMEDSwitzerlandfrom SRN EUDAMED FDA SRN CH-MF-000041617 FEI 3030452144
- Devices
- 1
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
What Artiria Medical SA makes
Artiria Medical SA manufactures the SmartGUIDE, a deflectable hydrophilic guidewire designed for enhanced navigability and precision in vascular procedures.
The SmartGUIDE is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
SmartGUIDE deflectable hydrophilic guidewire Ref K222690
Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID
Company details
- EUDAMED SRN
- CH-MF-000041617
- FDA FEI number
- 3030452144
- DUNS number
- 480422032
- EU VAT number
- CHE-318.546.300
- EUDAMED status
- Active
- EUDAMED registered name
- Artiria Medical SA
- Registered address
- 15, Campus Biotech, Chemin des Mines, 1202, Geneva, Switzerland
- Website
- www.artiria-medical.com/
- [email protected]
- PRRC contact
- Silvia Scarabelli
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 11 Nov 2030
Notified body 2443 2 certificates
- G11DK 111736 0003 Active
Quality management system EU MDR
- Issued
- 10 Apr 2026
- Expires
- 11 Nov 2030
- Reason
- Mnf data change
- G70DK 111736 0004 Active
Technical documentation EU MDR
- Issued
- 10 Apr 2026
- Expires
- 11 Nov 2030
- Reason
- Mnf data change
Frequently asked questions
How many devices does Artiria Medical SA have in the registry?
The registry currently lists 1 device for Artiria Medical SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Artiria Medical SA's devices?
Among its 1 most recently registered device, Artiria Medical SA has devices listed in EUDAMED (1 device), FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Artiria Medical SA's devices fall under?
Among its 1 most recently registered device, the classes recorded for Artiria Medical SA's devices are Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Artiria Medical SA?
EUDAMED lists 2 certificates for Artiria Medical SA (quality management system; technical documentation) under MDR. The most recent was issued on 2026-04-10.
What are the newest devices from Artiria Medical SA in the registry?
The most recently registered devices listed for Artiria Medical SA include SmartGUIDE deflectable hydrophilic guidewire.