FDA Registration
Active
🇦🇹 Austria
LEONHARD LANG GMBH
Reg #: 8020045
·
FEI: 6736
·
Expires 2026
Products
12
Proprietary Names
8
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- LEONHARD LANG GMBH
- Registration Number
- 8020045
- FEI Number
- 6736
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ARCHENWEG 56
- City
- INNSBRUCK Tirol
- Country
- AT
Regulatory Submissions
- 510(k) Number
- K024264
Owner / Operator
- Firm Name
- LEONHARD LANG GMBH
- Operator Number
- 8020045
- Address
- ARCHENWEG 56, --
- City
- INNSBRUCK
- State
- AT-NOTA
- Postal Code
- A-6020
- Country
- AT
- Correspondent
- BURRHUS - LANG
US Agent
- Business Name
- PALADIN MEDICAL, INC.
- Contact Name
- ELAINE DUNCAN, MS.ME., RAC, AIMBE
- Address
- 415 VALLEY VIEW TRAIL
- City
- HOULTON
- State
- WI
- ZIP
- 54082
- Country
- US
- [email protected]
- Phone
- 715 5496035
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2015-03-11 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2015-03-11 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2019-07-19 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2007-12-07 |
| Electrode, Electrocardiograph, Multi-Function | MLN | Class 2 | Cardiovascular | No | 2017-04-12 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2017-06-25 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2007-01-30 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2024-05-10 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-05-10 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2024-05-10 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2024-05-10 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2012-12-11 |
Proprietary Names
S&W ECG Electrodes
Skintact ECG Electrodes
others
Skintact
Skintact ECG Electrodes and accessories
S&W Healthcare
Skintact ESU Dispersive Electrodes
S&W ESU Dispersive Electrodes
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device