FDA Registration
Active
🇲🇽 Mexico
Foam Applicators
Reg #: 3012187635
·
FEI: 3012187635
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NOVEM MEDICAL S. DE R.L. DE C.V.
- Registration Number
- 3012187635
- FEI Number
- 3012187635
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- CALLE AMAPOLAS 65, COL LIBRAMIENTO
- City
- TIJUANA Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K130995
Owner / Operator
- Firm Name
- NOVEM MEDICAL S. DE R.L. DE C.V.
- Operator Number
- 10049894
- Address
- Calle Amapolas 65, Col Libramiento
- City
- TIJUANA
- State
- Baja California
- Postal Code
- 22225
- Country
- MX
- Correspondent
- ENRIQUE CASTRO
US Agent
- Business Name
- Primary Packaging
- Contact Name
- John Barron
- Address
- 26945 Cabot Road # 101
- City
- Laguna Hills
- State
- CA
- ZIP
- 92653
- Country
- US
- [email protected]
- Phone
- 949 2947077
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2019-04-24 |
Proprietary Names
Foam Applicators
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)