Medisoft S.A.
BE-MF-000000789 · Belgium · Sorinnes
Medisoft S.A. is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 18 |
|---|
Most frequent device types declared: BTL BodyBox, BTL Ergocard CPX Clinical, BTL Ergocard CPX Professional, BTL Expair, BTL FeNO+.
Among these devices, 17 are declared active, 18 with a measuring function.
Devices declared under this manufacturer
- BTL BodyBox
- BTL Ergocard CPX Clinical
- BTL Ergocard CPX Professional
- BTL Expair
- BTL FeNO+
- BTL HypAir
- BTL Micro 6000
- BTL SpiroAir
- Ergocard CPX Clinical
- Expair
- FeNo+ PFS
- HypAir PFS
Showing 12 of 18 declared devices.
Catalogue references include BB-00-01-BTL, ER-10-01-BTL, ERC-10-01, ERC-10-01-BTL, FE-00-01-BTL, HY-00-01-BTL.
European nomenclature codes declared: Z12150101,Z12159003,Z12159005,Z12159006,Z12159008, Z12150101,Z12159005,Z12159008, Z12150101,Z12159003,Z12159005,Z12159006,Z12159007,Z12159008, Z12050192,Z12150192,Z12159092,Z129092, Z12150101,Z12159006,Z12159008, Z12050101,Z12150101,Z12159006,Z12159008.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MEDISOFT S.A. (BE) · FDA 3003630525 |
| Devices in EUDAMED | 18 |
| Country of registration | Belgium |
Device-level evidence
| Devices with a numeric GTIN | 18 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 11.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDISOFT S.A. |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| First licensed | 2004-09-24 |
Licence types: Device Family (4), Single Device (1).
Licensed under: ERGOCARD, MICRO 5000, BODYBOX, HYPAIR, MICRO 6000.
North American profile: Both markets. Medisoft S.A. is registered in both the United States and Canada.