KARL STORZ SE & Co. KG
DE-MF-000005723 · Germany · Tuttlingen
KARL STORZ SE & Co. KG is registered in the European database on medical devices as a manufacturer, with 969 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 928 |
|---|---|
| Class IIb | 26 |
| Class I | 15 |
Among these devices, 36 are declared sterile, 6 reusable, 133 active.
Catalogue references include 051110-10, 10318L, 26176LML, 30103CS, 30142HB, 8404ZX.
European nomenclature codes declared: Z12011380, Z12010980, Z12029080, Z12020780, Z12019080, Z12020480.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | KARL STORZ SE & CO. KG (DE) · FDA 9610617 |
| Devices in EUDAMED | 969 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 969 |
|---|---|
| Found in the U.S. device database | 715 |
| Share | 73.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | KARL STORZ SE & CO. KG |
What it holds in Canada
| Licences on record | 190 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 186 |
| Class 3 devices | 4 |
| First licensed | 1999-06-28 |
Licence types: Device Family (106), System (31), Device Group Family (25), Single Device (25).
Licensed under: RESECTOSCOPE WORKING ELEMENTS - URO, LAP AND O, ELECTROSURGICAL ELECTRODES (FORCEPS, SCISSORS,, ENDOSCOPE ADAPTORS AND CONNECTORS, FLEXIBLE INTUBATION VIDEOENDOSCOPE, UNIDRIVE SELECT, SUCTION & IRRIGATION PUMPS - ARTHROSCOPY.
North American profile: Both markets. KARL STORZ SE & Co. KG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G70 084462 0201 | issued | 2031-06-01 |
G70 084462 0200 | issued | 2031-05-31 |