Specto Medical
Active in EUDAMEDSwitzerlandfrom SRN EUDAMED SRN CH-MF-000042032
Part of Specto Medical AG
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Specto Medical makes
Specto Medical manufactures the SpectoMed (v1.0), a medical device designed for diagnostic imaging or procedural guidance, though specific use cases are not detailed.
The SpectoMed (v1.0) is classified as a Class II device under FDA regulations and is listed via a 510(k) clearance. The company is based in the United States.
Catalogue
SpectoMed (v1.0) Ref K242205
Regimes: 510(k) Registry: 510(k)SpectoMED Ref 01
Regimes: CE MDR Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- CH-MF-000042032
- EUDAMED status
- Active
- EUDAMED registered name
- Specto Medical AG
- Registered address
- 18, Elisabethenstrasse, 4051, Basel, Switzerland
- Website
- www.spectomedical.com
- [email protected]
- Phone
- +41 61 294 60 60
- PRRC contact
- Charly Leprince
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 29 Apr 2030
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2508721-1 Active
Quality management system EU MDR
- Issued
- 30 Apr 2025
- Expires
- 29 Apr 2030
Frequently asked questions
How many devices does Specto Medical have in the registry?
The registry currently lists 2 devices for Specto Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Specto Medical's devices?
Among its 2 most recently registered devices, Specto Medical 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 Specto Medical's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Specto Medical's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Specto Medical?
EUDAMED lists 1 certificate for Specto Medical (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 30 Apr 2025.
What are the newest devices from Specto Medical in the registry?
The most recently registered devices listed for Specto Medical include SpectoMed (v1.0) and SpectoMED.