PentaBase A/S
DK-MF-000023157 · Denmark · Odense
PentaBase A/S is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: BRAF qPCR Assay, KIT qPCR Assay, KRAS qPCR Assay, MLH1 Methylation qPCR Assay, NRAS qPCR Assay.
Devices declared under this manufacturer
- BasePurifier
- BaseSNAP™ Sensitive Nucleic Acid Purification Kit
- BaseTyper
- CoviDetect
- CoviFLU
- EpiDirect® MGMT Methylation qPCR Assay
- EpiDirect® MLH1 Methylation qPCR Assay
- MicroSight® MSI 1-Step HRM Analysis
- PlentiPlex™ KIT Mastocytosis qPCR Assay
- PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay
- RespiDetect
- SensiScreen
Showing 12 of 33 declared devices.
Catalogue references include 1398;1402;1400;1831;1836;1841, 1500, 1771;-76,-81,86,96;1801,-11,-16,-21,-26;2000,-05,-10,-15,-25,-30,-40,-, 1849, 3055-1, 5525; 5530; 5535; 5336; 5341; 5346.
European nomenclature codes declared: W01060299, W02050116, W0599, W0105040519, W0105070503, W01060202.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 33 |
| Country of registration | Denmark |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 19 |
|---|---|
| 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. PentaBase A/S was not found in either the U.S. or the Canadian register.