Stihler Electronic GmbH
DE-MF-000006188 · Germany · Leinfelden-Echterdingen
Stihler Electronic GmbH is registered in the European database on medical devices as a manufacturer, with 57 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 33 |
|---|---|
| Class IIa | 24 |
Most frequent device types declared: AFP300CH, AFP300DK, AP220UK, COV105, COV150.
Among these devices, 1 are declared sterile, 36 active.
Devices declared under this manufacturer
- ASTODIA
- ASTOFLO PLUS ECO
- ASTOPAD
- ASTOPAD Reusable cover
- ASTOPAD fixation cover
- ASTOPAD mattress cover
- ASTOPAD reusable cover
- ASTOTHERM PLUS
- ASTOTHERM PLUS heat protection sleeve
- ASTOTUBE
Showing 12 of 57 declared devices.
Catalogue references include COV150, COV40105, ROE458, ROE8, SOF4, SOF405.
European nomenclature codes declared: A030105, T0210, Z12040208, Z110702, A03020199, V0880.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | STIHLER ELECTRONIC GMBH (DE) · FDA 9617473 |
| Devices in EUDAMED | 57 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 57 |
|---|---|
| Found in the U.S. device database | 15 |
| Share | 26.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | STIHLER ELECTRONIC GMBH |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 1999-07-22 |
Licence types: Single Device (2), Device Family (1), System (1).
Licensed under: BLOOD AND INFUSION WARMER, ASTOLINE (ACCESSORY HEATER), ASTOTUBE INFUSION EXTENSION, ASTOPAD PATIENT WARMING SYSTEM.
North American profile: Both markets. Stihler Electronic GmbH is registered in both the United States and Canada.