Zimmer MedizinSysteme GmbH
DE-MF-000006141 · Germany · Neu-Ulm
Zimmer MedizinSysteme GmbH is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 10 |
|---|
Most frequent device types declared: CardioAir, CardioAirPlus, CardioPortFour, CardioPortFour BT, PhySys.
Among these devices, 10 are declared active, 4 with a measuring function.
Devices declared under this manufacturer
- ECG Air
- ECG Air BT
- ECG Top BT
- ECG Top D
- PhySys 2-channel incl. Vaco unit
- Soleo Galva
- Soleo Sono
- Soleo Sonostim
- Soleo Vaco
Catalogue references include 1736, 4531, 5301, 5311, 5322, 5331.
European nomenclature codes declared: Z120602, Z12050301, Z12030292, Z12050380, C020501.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ZIMMER MEDIZINSYSTEME GMBH (DE) · FDA 8010720 |
| Devices in EUDAMED | 10 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 10 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ZIMMER MEDIZINSYSTEME GMBH |
What it holds in Canada
| Licences on record | 19 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 17 |
| Class 3 devices | 2 |
| First licensed | 2004-09-15 |
Licence types: System (13), Device Family (4), Device Group (2).
Licensed under: SYNERCOOL LASER COOLING DEVICE, CRYO UNITS (FOR LASER DEVICES), SOLEO SONOSTIM ULTRASOUND THERAPY DEVICE, ENPULS VERSION 2.0, PHYSYS, ENPULSPRO SHOCK WAVE THERAPY DEVICE.
North American profile: Both markets. Zimmer MedizinSysteme GmbH is registered in both the United States and Canada.