Spectrum Medical Ltd
GB-MF-000033594 · United Kingdom · Gloucester
Spectrum Medical Ltd is registered in the European database on medical devices as a manufacturer, with 30 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 29 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: QMPDM22, QPF2, QPSL.
Among these devices, 1 are declared active.
Authorised representative in the Union: Spectrum Medical S.r.l..
Catalogue references include 43-000955-00, 51-000126-00, 52-000027-00, 52-000045-00, 52-000056-00, 52-000141-00.
European nomenclature codes declared: Z12050280, C030199, Z129004, Z12030201, C99, Z12050201.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SPECTRUM MEDICAL LTD (GB) · FDA 3006073153 |
| Devices in EUDAMED | 30 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 30 |
|---|---|
| Found in the U.S. device database | 19 |
| Share | 63.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SPECTRUM MEDICAL LTD. |
North American profile: Both markets. Spectrum Medical Ltd is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 2648948 1 | issued | 2031-04-27 |