FDA Registration
Active
🇸🇮 Slovenia
L-TEK D.O.O.
Reg #: 3015282442
·
FEI: 3015282442
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- L-TEK D.O.O.
- Registration Number
- 3015282442
- FEI Number
- 3015282442
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Cesta Milosa Kovacicia
- City
- Sentjernej Ljubljana
- Country
- SI
Owner / Operator
- Firm Name
- L-Tek d.o.o.
- Operator Number
- 10059897
- Address
- Cest Milosa Kovacicia
- City
- Sentjernej
- State
- Ljubljana
- Postal Code
- 8310
- Country
- SI
US Agent
- Business Name
- Aztech Regulatory and Quality LLC
- Contact Name
- Joseph Azary
- Address
- 543 Long Hill Ave
- City
- Shelton
- State
- CT
- ZIP
- 06484
- Country
- US
- [email protected]
- Phone
- 203 2426670
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Exerciser, Measuring | ISD | Class 2 | Physical Medicine | No | 2026-01-18 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2023-08-31 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2023-08-31 |
| Oscillometer | DRZ | Class 2 | Cardiovascular | No | 2022-01-26 |
| System, Pressure Measurement, Intermittent | JFC | Class 1 | Physical Medicine | No | 2026-01-18 |
Proprietary Names
Nushu
Sleepiz
Oscillometer - Sleepiz
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)