Leonhard Lang GmbH
AT-MF-000000426 · Austria · Innsbruck
Leonhard Lang GmbH is registered in the European database on medical devices as a manufacturer, with 144 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 141 |
|---|---|
| Class IIb | 3 |
Devices declared under this manufacturer
- ASMUTH
- GE HealthCare
- PATZ
- RATIOMED
- S & W
- SCHILLER
- STABLE BASE
- SilverTRACE
- Skintact
- XLBLEU
- hestomed
- medida
Showing 12 of 144 declared devices.
Catalogue references include 165.FS-50, ELT-F50W-1200, F-50C, FS-521, NEO50-F4C, T-VO01.
European nomenclature codes declared: C020501, C020401, K02010202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LEONHARD LANG GMBH (AT) · FDA 8020045 |
| Devices in EUDAMED | 144 |
| Country of registration | Austria |
Device-level evidence
| Devices with a numeric GTIN | 144 |
|---|---|
| Found in the U.S. device database | 34 |
| Share | 23.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LEONHARD LANG GMBH |
What it holds in Canada
| Licences on record | 9 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 9 |
| First licensed | 2005-04-29 |
Licence types: Device Family (8), Single Device (1).
Licensed under: SKINTACT ECG TAB ELECTRODES, SKINTACT MULTIFUNCTION ELECTRODES, SKINTACT ECG ELECTRODES, SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDIN, SKINTACT EASICLIP, SKINTACT PRE-WIRED ECG ELECTRODES.
North American profile: Both markets. Leonhard Lang GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 027361 0016 | issued | 2029-04-02 |