CEM SRL
IT-MF-000017624 · Italy · Prato
CEM SRL is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 13 |
|---|
Most frequent device types declared: COPRIMATERASSO ANTALGICO IPOHPHARMA, FEDERA ANTALGICA IPOHPHARMA, POWER ANTALGIC COPRIMATERASSO ANTALGICO, POWER ANTALGIC FEDERCA ANTALGICA, ZEPTER ANTALGIC PILLOW.
Devices declared under this manufacturer
- COPRIMATERASSO ANTALGICO IPOHPHARMA
- FEDERA ANTALGICA IPOHPHARMA
- GUAM FUSEAUX FIBROACT ANTALGICO E ANTINFIAMMATORIO
- POWER ANTALGIC COPRIMATERASSO ANTALGICO
- POWER ANTALGIC COPRIMATERASSO/TOPPER
- POWER ANTALGIC FASCIA RENALE POWERBACK
- POWER ANTALGIC FEDERCA ANTALGICA
- ZEPTER ANTALGIC PILLOW
- ZEPTER ANTALGIC PILLOWCASE
- ZEPTER ANTALGIC BACK BELT
- ZEPTER ANTALGIC MATTRESS
- ZEPTER ANTALGIC MATTRESS COVER
Showing 12 of 13 declared devices.
Catalogue references include 2581633, 2581645 (D) 2581652 (E), 2581655, 2581666, 2581673, 2581683.
European nomenclature codes declared: V0880, V080702, V08030102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 13 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 13 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. CEM SRL was not found in either the U.S. or the Canadian register.