STORZ MEDICAL AG
CH-MF-000014374 · Switzerland · Tägerwilen
STORZ MEDICAL AG is registered in the European database on medical devices as a manufacturer, with 61 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 41 |
|---|---|
| Class IIb | 20 |
Most frequent device types declared: 23232.0100.
Among these devices, 61 are declared active.
Authorised representative in the Union: STORZ MEDICAL Deutschland GmbH.
Devices declared under this manufacturer
- CHATTANOOGA Intelect RPW Lite
- CHATTANOOGA MOBILE 2 RPW - 2905
- D-ACTOR 200
- D-ACTOR ONE
- MAGNETOLITH
- MASTERPULS MP100
- MASTERPULS MP200
- MASTERPULS MP50
- MASTERPULS ONE
- MASTERPULS R-SW100
- MASTERPULS icon
- MODULITH SLC
Showing 12 of 61 declared devices.
Catalogue references include 19576.0100, 19700.0100, 19700.1001, 23232.0102, 23232.0103, 23232.1000.
European nomenclature codes declared: Z120622,Z12139001, Z120622,Z12101106,Z12139001,Z12169002,Z12169004, Z12160101, Z12040203,Z12040205,Z120622,Z12101106,Z12139001,Z12169002,Z12169004, Z12040203,Z120622,Z12101106,Z12139001,Z12169002,Z12169004, Z12139001.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | STORZ MEDICAL AG (CH) · FDA 9613347 |
| Devices in EUDAMED | 61 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 61 |
|---|---|
| Found in the U.S. device database | 11 |
| Share | 18.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | STORZ MEDICAL AG |
What it holds in Canada
| Licences on record | 18 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 13 |
| Class 3 devices | 5 |
| First licensed | 2004-04-16 |
Licence types: Device Family (6), System (4), Single Device (4), Device Group Family (2).
Licensed under: MODULITH LITHOTRIPSY UNITS, X-RAY SYSTEM XR MX, MASTERPULS MP100 SYSTEM, DUOLITH SD1 SYSTEM, MODULITH SLC CARDIAC SHOCK WAVE THERAPY DEVICE, HANDPIECES.
North American profile: Both markets. STORZ MEDICAL AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1620952-1 | supplemented | 2028-06-14 |