Signifier Medical Technologies, Ltd.
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000035054 FEI 3018192374
- Devices
- 7
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- Advena LimitedMT
Catalogue
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
eXciteOSA with remote and eXciteOSA without remote Ref DEN200018
Regimes: De Novo Registry: De Novo- Regimes: 510(k) Registry: 510(k)
eXciteOSA Ref eXciteOSA control unit
Regimes: CE MDR Registry: EUDAMEDGUDIDeXciteOSA Ref eXciteOSA mouthpiece
Regimes: CE MDR Registry: EUDAMEDGUDID- Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- GB-MF-000035054
- FDA FEI number
- 3018192374
- EU VAT number
- GB234756886
- EUDAMED status
- Active
- EUDAMED registered name
- Signifier Medical Technologies Limited
- EUDAMED abbreviated name
- SMT
- Registered address
- 59, King Street, M2 4PD, Manchester, United Kingdom (ex Northern Ireland)
- [email protected]
- PRRC contact
- Mariam Ismail
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 2 Dec 2029
ENTE CERTIFICAZIONE MACCHINE SRL 1282 1 certificate
- ECM24MDR011 Active
Quality assurance EU MDR
- Issued
- 3 Dec 2024
- Expires
- 2 Dec 2029
Frequently asked questions
How many devices does Signifier Medical Technologies, Ltd. have in the registry?
The registry currently lists 7 devices for Signifier Medical Technologies, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Signifier Medical Technologies, Ltd.'s devices?
Among its 7 most recently registered devices, Signifier Medical Technologies, Ltd. has devices listed in EUDAMED (3 devices), FDA 510(k) (3 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Signifier Medical Technologies, Ltd.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Signifier Medical Technologies, Ltd.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Signifier Medical Technologies, Ltd.?
EUDAMED lists 1 certificate for Signifier Medical Technologies, Ltd. (quality assurance) under MDR. 1 is recorded with the status issued. The most recent was issued on 3 Dec 2024.
What are the newest devices from Signifier Medical Technologies, Ltd. in the registry?
The most recently registered devices listed for Signifier Medical Technologies, Ltd. include eXciteOSA 810000000, eXciteOSA without remote control (3000); eXciteOSA with remote control (6000), eXciteOSA with remote and eXciteOSA without remote and eXciteOSA.