Nordic Biomarker AB
SE-MF-000022201 · Sweden · Umeå
Nordic Biomarker AB is registered in the European database on medical devices as a manufacturer, with 54 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- D-Dimer Calibrator
- D-Dimer Latex LRT
- MRX Fib Clauss Calibrator
- MRX Free Protein S Calibrator
- MRX Green D-dimer
- MRX Green FDP
- MRX PT Buffer
- MRX PT Buffer S
- MRX PT Owren
- MRX PT Quick
- MRX PT Quick (INR) Calibrator Set
- MRX Protein C
Showing 12 of 54 declared devices.
Catalogue references include K5009, K5020, K5024, K5026, K5042, K5043.
European nomenclature codes declared: W0103020701, W0103020903, W0103020199, W0103020702, W0103020503, W0103020612.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 54 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 54 |
|---|---|
| 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. Nordic Biomarker AB was not found in either the U.S. or the Canadian register.