FDA Registration
Active
🇲🇽 Mexico
Biotronick, Inc.
Reg #: 9680001
·
FEI: 3002808445
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Venusa de Mexico S. de R.L de C.V
- Registration Number
- 9680001
- FEI Number
- 3002808445
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- CALLE HERTZ 1525, Parque Industrial Antonio J. Bermudez
- City
- CIUDAD JUAREZ Chihuahua
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K212593
Owner / Operator
- Firm Name
- Lake Region Medical
- Operator Number
- 9048369
- Address
- 340 Lake Hazeltine Drive
- City
- Chaska
- State
- MN
- Postal Code
- 55318
- Country
- US
US Agent
- Business Name
- Lake Region Medical
- Contact Name
- Paul Trnka
- Address
- 340 Lake Hazeltine Drive, Bldg. C
- City
- Chaska
- State
- MN
- ZIP
- 55318
- Country
- US
- [email protected]
- Phone
- 952 6418396
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2022-03-23 |
Proprietary Names
Biotronick, Inc.
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)