Stryker GmbH
CH-MF-000009332 · Switzerland · Selzach
Stryker GmbH is registered in the European database on medical devices as a manufacturer, with 7 152 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 6 547 |
|---|---|
| Class IIa | 605 |
Most frequent device types declared: 08858251002995U4, 08858251003268T5, 08858251004356TA, 08858251004519TE, 08858251004534TA.
Among these devices, 3 190 are declared sterile, 6 546 implantable, 100 reusable, 3 active.
Authorised representative in the Union: Stryker European Operations Limited.
Devices declared under this manufacturer
- Anchorage®
- Anchorage® 2 CP
- Apex®
- Asnis® III
- Asnis® PRO
- Bixcut®
- Fixos® II
- Pangea
- SPS™
- SPS™ Large Fragment
- VARIAX®
- VARIAX® 2
Showing 12 of 7 152 declared devices.
Catalogue references include 325236, 341065, 343330, 614510S, 619915, 620415S.
European nomenclature codes declared: P09120601, P09120599, P09120603, P09120499, P091280, P09120602.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | STRYKER GmbH (CH) · FDA 8031020 |
| Devices in EUDAMED | 7 152 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 7 152 |
|---|---|
| Found in the U.S. device database | 5 918 |
| Share | 82.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | STRYKER GMBH |
What it holds in Canada
| Licences on record | 124 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 44 |
| Class 3 devices | 80 |
| First licensed | 1999-08-13 |
Licence types: System (60), Device Family (50), Single Device (7), Device Group Family (6).
Licensed under: KNIFELIGHT, MONTICELLI/SPINELLI EXTERNAL FIXATION SYSTEM, MONOTUBE EXTERNAL FIXATOR SYSTEM, APEX PINS, GROSSE & KEMPF UNSLOTTED LOCKING NAIL SYSTEM, OMEGA COMPRESSION HIP SCREW SYSTEM.
North American profile: Both markets. Stryker GmbH is registered in both the United States and Canada.