Stryker Leibinger GmbH & Co.KG
DE-MF-000005522 · Germany · Freiburg
Stryker Leibinger GmbH & Co.KG is registered in the European database on medical devices as a manufacturer, with 248 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 174 |
|---|---|
| Class IIa | 74 |
Most frequent device types declared: 08858250000552RX, 08858251001885TM, 08858251001888TT, 08858251001900SQ, 08858251002084SJ.
Among these devices, 66 are declared sterile, 174 implantable.
Devices declared under this manufacturer
- MMF AXS
- Stryker VariSpeed
- UNIVERSAL NEURO 3
- UNIVERSAL NEURO III
- Universal Neuro 3
Showing 12 of 248 declared devices.
Catalogue references include 53-00346S, 53-00382, 53-34212S, 53-36212, 56-90316S, 56-90612.
European nomenclature codes declared: P09120503, S010401, P091280, P900403, Z12011480.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | STRYKER LEIBINGER GMBH & CO. KG (DE) · FDA 8010177 |
| Devices in EUDAMED | 248 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 248 |
|---|---|
| Found in the U.S. device database | 201 |
| Share | 81.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | STRYKER LEIBINGER GMBH & CO. KG |
What it holds in Canada
| Licences on record | 70 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 32 |
| Class 3 devices | 37 |
| Class 4 devices | 1 |
| First licensed | 1998-08-20 |
Licence types: Device Family (33), System (27), Single Device (8), Device Group Family (2).
Licensed under: THE COLORADO MICRO NEEDLE, MEDPOR SURGICAL IMPLANT MATERIAL, LIGATURE WIRE, STRYKER NAVIGATION SYSTEM, LEIBINGER BONE PLATES - TITANIUM MESH, DELTA SYSTEM.
North American profile: Both markets. Stryker Leibinger GmbH & Co.KG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1762136-1 | supplemented | 2025-12-21 |
HZ 1762136-1 | reissued | 2030-12-21 |