Mercodia AB
SE-MF-000005175 · Sweden · UPPSALA
Mercodia AB is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: Mercodia Insulin ELISA.
Devices declared under this manufacturer
- Mercodia C-peptide ELISA
- Mercodia Diabetes Antigen Control (Low, High) / Human
- Mercodia Glucagon ELISA
- Mercodia Insulin ELISA
- Mercodia Insulin ELISA – 10 pack
- Mercodia Iso-Insulin ELISA
- Mercodia Lp(a) ELISA
- Mercodia Oxidized LDL ELISA
- Mercodia Proinsulin ELISA
- Mercodia Ultrasensitive C-peptide ELISA
- Mercodia Ultrasensitive Insulin ELISA
Catalogue references include 10-1113-01, 10-1113-10, 10-1128-01, 10-1132-01, 10-1136-01, 10-1141-01.
European nomenclature codes declared: W0102060103, W0102060101, W0102152099, W0102060102, W0102010403, W0102010405.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MERCODIA AB (SE) · FDA 3003356736 |
| Devices in EUDAMED | 11 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 11 |
|---|---|
| Found in the U.S. device database | 9 |
| Share | 81.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MERCODIA AB |
What it holds in Canada
| Licences on record | 10 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 10 |
| First licensed | 2011-04-14 |
Licence types: Test Kit (9), Device Family (1).
Licensed under: MERCODIA LP(A) ELISA, MERCODIA PROINSULIN ELISA, MERCODIA INSULIN ELISA, MERCODIA C-PEPTIDE ELISA, MERCODIA ULTRASENSITIVE INSULIN ELISA, MERCODIA ULTRASENSITIVE C-PEPTIDE ELISA.
North American profile: Both markets. Mercodia AB is registered in both the United States and Canada.