Chema Diagnostica Srl
IT-MF-000009128 · Italy · Monsano AN
Chema Diagnostica Srl is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: AF F080 CH, AF F245 CH, AF F400 CH, AL 2H400, AL F080 CH.
Devices declared under this manufacturer
- ALKALINE PHOSPHATASE FL DGKC
- ALKALINE PHOSPHATASE FL IFCC
- CALCIUM
- PHOSPHORUS UV
- URIC ACID T FL
- ZINC
Showing 12 of 23 declared devices.
Catalogue references include AL 2H400, AL F245 CH, AL F400 CH, AU F100 CH, AU F250 CH, AU F402 CH.
European nomenclature codes declared: W01010105, W01010307, W01010232, W01010303, W01010233.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 23 |
| 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 | 23 |
|---|---|
| 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. Chema Diagnostica Srl was not found in either the U.S. or the Canadian register.