FDA Registration
Active
🇭🇷 Croatia
BEAR 2
Reg #: 3014747097
·
FEI: 3014747097
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MOTUS EUROPE
- Registration Number
- 3014747097
- FEI Number
- 3014747097
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Radnicka Cesta 202
- City
- Zagreb Zagreb, Grad
- Country
- HR
Regulatory Submissions
- 510(k) Number
- K200803
Owner / Operator
- Firm Name
- MOTUS EUROPE
- Operator Number
- 10058850
- Address
- Radnicka Cesta 202
- City
- Zagreb
- State
- Zagreb, Grad
- Postal Code
- 10000
- Country
- HR
- Correspondent
- Vanja Sikic
US Agent
- Business Name
- LELO INC.
- Contact Name
- Pavle Sedic
- Address
- 5799 Fontonoso Way
- City
- San Jose
- State
- CA
- ZIP
- 95138
- Country
- US
- [email protected]
- Phone
- 408 3558860
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | Class 2 | Neurology | No | 2020-11-08 |
Proprietary Names
BEAR 2
BEAR
BEAR mini
BEAR eyes and lips
BEAR 2 go
Establishment Types
Export Device to the United States But Perform No Other Operation on Device