Spectrum Dynamics Medical SA
CH-MF-000032669 · Switzerland · Morges
Spectrum Dynamics Medical SA is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 3 |
|---|---|
| Class IIb | 7 |
Most frequent device types declared: 001, Model 004, TruSPECT, VERITON CT.
Authorised representative in the Union: SPECTRUM DYNAMICS MEDICAL FRANCE SAS.
Devices declared under this manufacturer
- D-SPECT CARDIO
- D-SPECT VISTA
- TruSPECT
- VERITON CT 216
- VERITON CT 264
- VERITON CT 316
- VERITON CT 364
- VERITON CT 416
- VERITON CT 464
- VERITON NM
Catalogue references include 8010121-01, 8010172-01, 8010184-01, 8010267-01, 8010290-01, 8010419-01.
European nomenclature codes declared: Z11020201, Z11020104, Z11020105, Z11029082.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Spectrum Dynamics Medical Ltd. (IL) · FDA 3006209933 |
| Devices in EUDAMED | 10 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 10 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SPECTRUM DYNAMICS MEDICAL LTD. |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 2 |
| First licensed | 2009-03-19 |
Licence types: System (4).
Licensed under: D-SPECT CARDIAC SCANNER SYSTEM, D-SPECT VISTA, VERITON CT 16 SYSTEM, VERITON CT 64 SYSTEM.
North American profile: Both markets. Spectrum Dynamics Medical SA is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
3902983CE02 | issued | 2027-11-01 |
3902983CE01 | amended | 2027-11-01 |