Pharma Systems AB
SE-MF-000018545 · Sweden · Lysekil
Pharma Systems AB is registered in the European database on medical devices as a manufacturer, with 190 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 190 |
|---|
Among these devices, 96 are declared sterile.
Devices declared under this manufacturer
- Bact HME Port and PharmaFlex Swivel Port
- Bact Trap Mini Port and Elbow
- Bact-HME Basic
- Bact-HME Midi Port
- Bact-Trap Mini Port 2
- HME 10 Port 2
- HME Midi 11 Angle
- HME Midi 11 Port
- Oxygen Supply Tube
- Pharma Mini Port Angle
- Pharma Neo Port
- Pharma Trach Multi-Function
Showing 12 of 190 declared devices.
Catalogue references include 6046, 6130t, 6220, 6241, 6245, 6261s.
European nomenclature codes declared: R060299, R040102, R040101, R020299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PHARMA SYSTEMS AB (SE) · FDA 3005519819 |
| Devices in EUDAMED | 190 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 190 |
|---|---|
| Found in the U.S. device database | 40 |
| Share | 21.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PHARMASYSTEMS INC. |
What it holds in Canada
| Licences on record | 6 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 6 |
| First licensed | 2002-02-28 |
Licence types: Device Family (5), Single Device (1).
Licensed under: PHARMASYSTEMS DIGITAL THERMOMETERS, LATEX FINGER COTS, ISOSAF ENTERAL SYRINGE-LOW DOSE, ISOSAF ENTERAL SYRINGE, ISOSAF AMBER BARREL ENTERAL SYRINGE- LOW DOSE, ISOSAF AMBER BARREL ENTERAL SYRINGE.
North American profile: Both markets. Pharma Systems AB is registered in both the United States and Canada.