Pentapharm AG
CH-MF-000020620 · Switzerland · Aesch BL
Pentapharm AG 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
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- APCr
- APCr Controls
- Batroxobin Time
- Pefaclot® UFH Controls
- Pefaclot® UFH
- Pefakit® APC-R Factor V Leiden Controls
- Pefakit® APC-R Faktor V Leiden
- Pefakit® Reptilase® Time
Catalogue references include 08013934190, 08045232190, 09134867190, 502-01, 502-21, 505-50.
European nomenclature codes declared: W0103020610, W0103020702, W0103020103, W0103020104.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PENTAPHARM AG (CH) · FDA 1000340866 |
| Devices in EUDAMED | 11 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 11 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PENTAPHARM AG |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| First licensed | 2021-09-23 |
Licence types: Test Kit (3).
Licensed under: PEFAKIT APC-R FACTOR V LEIDEN ASSAY, APC RESISTANCE AND APCR CONTROLS, BATROXOBIN TIME.
North American profile: Both markets. Pentapharm AG is registered in both the United States and Canada.