Systelab Technologies S.A.
Active in EUDAMEDSpainfrom SRN EUDAMED SRN ES-MF-000000383
- Devices
- 4
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
Parma GTS Ref SLT-SYSTAOV12
Parma GTS Ref 129-SYSTAO_v10
Result Flagging Module Ref 129-MMRF_V2
ParmaGTS Ref 129-SYSTAO_v11
Company details
- EUDAMED SRN
- ES-MF-000000383
- EU VAT number
- A58333287
- EUDAMED status
- Active
- EUDAMED registered name
- Systelab Technologies S.A.
- Registered address
- 7, Avenida Can Montcau, 08186, Lliçà d'Amunt, Spain
- [email protected]
- Phone
- +34 938609001
- PRRC contact
- Elena Raja Prado
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 26 Sep 2028
TÜV SÜD Product Service GmbH 0123 1 certificate
- G10 112514 0002 Issued
Quality management system EU MDR
- Issued
- 27 Sep 2023
- Expires
- 26 Sep 2028
What Systelab Technologies S.A. makes
Systelab Technologies S.A. manufactures medical devices including the Parma GTS, a system for automated processing and analysis of laboratory samples, and the Result Flagging Module, which supports automated identification and notification of abnormal test results. The ParmaGTS appears to be a variant or related system for sample management and testing workflows.
The company’s portfolio includes devices classified as Class A and Class I under EU regulations, all of which are registered in the EU’s eudamed database. The manufacturer is based in Spain.
Frequently asked questions
How many devices does Systelab Technologies S.A. have in the registry?
The registry currently lists 4 devices for Systelab Technologies S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Systelab Technologies S.A.'s devices?
Among its 4 most recently registered devices, Systelab Technologies S.A. has devices listed in EUDAMED (4 devices).
What risk classes do Systelab Technologies S.A.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Systelab Technologies S.A.'s devices are Class I, Class IIa and IVDR Class A. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Systelab Technologies S.A.?
EUDAMED lists 1 certificate for Systelab Technologies S.A. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2023-09-27.
What are the newest devices from Systelab Technologies S.A. in the registry?
The most recently registered devices listed for Systelab Technologies S.A. include Parma GTS, Result Flagging Module and ParmaGTS.