FDA Registration
Active
🇦🇷 Argentina
Ventilator Model Neumovent GraphNet
Reg #: 3009302812
·
FEI: 3009302812
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Tecme SA
- Registration Number
- 3009302812
- FEI Number
- 3009302812
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Av. Circunvalacion (N-O) Agustin Tosco 3040
- City
- Cordoba
- Country
- AR
Regulatory Submissions
- 510(k) Number
- K101401
Owner / Operator
- Firm Name
- Tecme S.A.
- Operator Number
- 10034919
- Address
- Av. Circunvalacion (N-O) Agustin Tosco 3040
- City
- Cordoba
- State
- AR-X
- Postal Code
- X5008HJY
- Country
- AR
- Correspondent
- Ernesto M Mana Escuti
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2011-01-16 |
Proprietary Names
Ventilator Model Neumovent GraphNet
Establishment Types
Manufacture Medical Device