MAK-SYSTEM Group Ltd.
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000026178 FEI 3002807672
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
Catalogue
- CE IVDR EUDAMED
- CE IVDR EUDAMED
- CE IVDR EUDAMED
eTraceLine Ref eTraceLine (eTL)
CE IVDR EUDAMEDGUDID
Company details
- EUDAMED SRN
- GB-MF-000026178
- FDA FEI number
- 3002807672
- EUDAMED status
- Active
- EUDAMED registered name
- MAK-SYSTEM Group Ltd.
- Registered address
- E14 5HU, London, United Kingdom (ex Northern Ireland)
- [email protected]
- PRRC contact
- Stephane Sajot
FDA establishments
- Mak-System Group Limited US
Frequently asked questions
How many devices does MAK-SYSTEM Group Ltd. have in the registry?
The registry currently lists 4 devices for MAK-SYSTEM Group Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list MAK-SYSTEM Group Ltd.'s devices?
Among its 4 most recently registered devices, MAK-SYSTEM Group Ltd. has devices listed in EUDAMED (4 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do MAK-SYSTEM Group Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for MAK-SYSTEM Group Ltd.'s devices are IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from MAK-SYSTEM Group Ltd. in the registry?
The most recently registered devices listed for MAK-SYSTEM Group Ltd. include eTraceLine, T.C.S. and COSMAS.
Which FDA establishments are linked to MAK-SYSTEM Group Ltd.?
1 FDA establishment is linked to MAK-SYSTEM Group Ltd. in the registry; they are listed on the company page.