Irt Systems
Active in EUDAMEDGermanyfrom SRN EUDAMED SRN DE-MF-000013778
Part of iRT Systems GmbH
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
IQM Integral Quality Monitor (also IQM) Ref K162629
Regimes: CE MDR 510(k) Registry: 510(k)IQM Integral Quality Monitor Ref 1013
Regimes: CE MDR Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- DE-MF-000013778
- EU VAT number
- DE286022265
- EUDAMED status
- Active
- EUDAMED registered name
- iRT Systems GmbH
- Registered address
- 1, Schlossstrasse, 56068, Koblenz, Germany
- Website
- www.i-rt.de
- [email protected]
- Phone
- +49 261 91545-0
- PRRC contact
- Thesi Roestel
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 10 Oct 2028
DQS Medizinprodukte GmbH 0297 1 certificate
- 1000169828 Active
Quality management system EU MDR
- Issued
- 3 Apr 2024
- Expires
- 10 Oct 2028
Frequently asked questions
How many devices does Irt Systems have in the registry?
The registry currently lists 2 devices for Irt Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Irt Systems's devices?
Among its 2 most recently registered devices, Irt Systems 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 Irt Systems's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Irt Systems's devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Irt Systems?
EUDAMED lists 1 certificate for Irt Systems (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 3 Apr 2024.
What are the newest devices from Irt Systems in the registry?
The most recently registered devices listed for Irt Systems include IQM Integral Quality Monitor (also IQM) and IQM Integral Quality Monitor.